Reported trial results for Migraine

Every Migraine trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

119 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

NCT05989048 · results posted 22 May 2026

According to the results reported on ClinicalTrials.gov, this trial looked at a nasal spray medicine called zavegepant compared to a dummy spray (placebo) for the treatment of migraine. A total of 708 people were assigned to the zavegepant group and 706 to the placebo group, with the vast majority completing the trial. The trial was measuring two main things at two hours after taking the spray: whether participants reported being completely free of head pain, and whether they were free from their most bothersome migraine symptom — which each participant had nominated beforehand from nausea, sensitivity to light, or sensitivity to sound. The reported data shows that, at two hours after taking the spray, 23.2% of people in the zavegepant group reported being completely free of head pain, compared with 14.1% in the placebo group. For freedom from the most bothersome symptom at two hours, 52.7% of the zavegepant group reported this, compared with 39.9% in the placebo group. The reported data also shows results from additional measurements: at 15 minutes, 14.5% of the zavegepant group and 10.9% of the placebo group reported their pain had reduced to none or mild; at 30 minutes, those figures were 30.3% and 24.1% respectively; and at two hours, 67.2% of the zavegepant group and 51.0% of the placebo group reported pain at none or mild levels. Regarding the ability to function normally at two hours, 38.0% of the zavegepant group reported returning to normal function, compared with 24.4% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05518123 · results posted 22 May 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 658 people in total — 330 in one group and 328 in another. The trial was set up in two stages: a 12-week "double-blind" phase (where neither participants nor researchers knew who was receiving the active medicine, rimegepant, or a dummy pill called a placebo), followed by an open-label phase where everyone received rimegepant. The main thing the trial was measuring was how much the number of migraine days per month changed compared to a baseline observation period recorded before treatment began. The reported data shows that, over the full 12-week double-blind period, people in the rimegepant group had on average 2.1 fewer migraine days per month compared to their starting point, while those in the placebo group had on average 0.5 fewer migraine days per month. Looking at just the first four weeks, the reported figures were a reduction of 1.8 days per month for rimegepant and 0.1 days for placebo; in the final four weeks (weeks 9 to 12), the reported figures were 2.3 fewer days for rimegepant and 0.9 fewer days for placebo. Among the secondary measures, the reported data shows that 34.0% of participants taking rimegepant had at least a 50% drop in their number of moderate-to-severe migraine days per month, compared with 13.8% in the placebo group. On a quality-of-life questionnaire related to migraines (scored 0–100, where higher means better quality of life), the rimegepant group showed an average improvement of 21.1 points versus 14.6 points for placebo. On a separate scale measuring the burden of migraines between attacks (scored 0–12, where lower means less burden), the rimegepant group showed an average decrease of 1.9 points compared with 1.0 points for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT05509400 · results posted 21 April 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT05509400) enrolled 633 people in total — 317 in one group and 316 in another. In the first part of the trial (the "double-blind" phase), participants were randomly assigned to take either rimegepant or a placebo (a dummy pill with no active ingredient) when they had a migraine attack, without knowing which one they received. The trial was primarily measuring how many people experienced pain relief two hours after taking their assigned treatment. Most participants then moved into a second open-label phase, where everyone received rimegepant and knew they were taking it. The reported data shows that in the double-blind phase, 55.9% of participants who took rimegepant reported pain relief (meaning their pain dropped to none or mild) at the two-hour mark, compared with 32.7% of those who took the placebo. For complete pain freedom at two hours, the reported figures were 22.7% for the rimegepant group and 7.4% for the placebo group. Regarding the use of additional "rescue" pain medicines within 24 hours, 18.0% of the rimegepant group used them compared with 46.2% in the placebo group. On returning to normal everyday functioning at two hours, 28.9% of the rimegepant group and 12.7% of the placebo group were reported to have done so. When looking at whether that return to normal functioning was maintained all the way through to 24 hours, the figures were 18.1% versus 6.8%, and out to 48 hours, 15.9% versus 4.2%. It is worth noting that these numbers simply describe what was recorded and counted during the trial — they do not on their own tell us whether any difference is meaningful for any individual person. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04404439 · results posted 16 April 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 78 people who experienced tinnitus (ringing or noise in the ears). Participants were randomly assigned to one of three groups: 23 people received a combination of nortriptyline and topiramate, 28 received a combination of verapamil and paroxetine, and 27 received a placebo (a dummy treatment with no active ingredients). The trial's main goal was to measure changes in how much tinnitus affected participants' daily lives, using a questionnaire called the Tinnitus Functional Index (TFI), which is scored from 0 to 100 — where a higher score means tinnitus is having a greater impact. A drop of 13 or more points on this scale was considered a meaningful change by the researchers. The reported data shows that, after eight weeks, the average TFI score dropped by 12.1 points in the nortriptyline and topiramate group, by 12.4 points in the verapamil and paroxetine group, and by 6.0 points in the placebo group. On the secondary questionnaires, the reported data shows smaller average changes. For depression symptoms (scored 0–27), scores dropped by 3.1, 0.6, and 0.7 points respectively across the three groups. For perceived stress (scored 0–40), scores dropped by 3.0 and 2.0 points in the two medication groups, while the placebo group's score increased slightly by 0.5 points. For sleep quality (scored 0–21, where lower is better), the changes were small: +0.3, −0.6, and +0.1 points. For anxiety symptoms (scored 0–21), scores dropped by 2.5 and 2.7 points in the medication groups, while the placebo group's score was almost unchanged at −0.04 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03844412 · results posted 19 March 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT03844412) enrolled 209 participants across four groups: a combined treatment group (52 people), a peripheral treatment-only group (52 people), a central treatment-only group (52 people), and a placebo group (53 people). The trial was measuring pain and wellbeing in people with a condition called vestibulodynia — a type of vulvar pain — using several questionnaires and a tampon insertion test. Not everyone who started finished the trial: completion numbers ranged from 34 people in the peripheral treatment group to 47 in the central treatment group. The reported data shows that on the tampon test — where participants rated their pain from 0 (no pain) to 10 (worst possible pain) — scores at the end of the study were between approximately 2.7 and 3.6 across all four groups, down from starting scores that ranged roughly from 3.8 to 4.4. On the McGill Pain Questionnaire (a 0–45 scale where higher means more pain), all four groups reported a decrease in their scores over the course of the trial, with changes ranging from about −4.6 to −5.2 points. On the sexual health measure (scored 0–100, with 50 being the population average), end-of-study scores across groups ranged from roughly 43 to 46, up slightly from starting scores of around 41–42. For physical health and mental health quality-of-life scores, the reported data shows results were only broken down into two subgroups (peripheral and central vestibulodynia), not the four treatment groups — physical health scores were reported as 55.1 and 49.2 respectively, while mental health scores were 36.9 and 36.5, both notably below the general population average of 50. On the cotton-swab pressure pain test, the reported data shows changes in pain scores varied across groups and time points, with figures ranging from around −0.4 to −3.6. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT03982316 · results posted 11 March 2026

According to the results reported on ClinicalTrials.gov, this trial looked at a telehealth-based programme called Telehealth Behavioral Migraine Management (TeleBMM) for people with migraines. The trial had three groups: TeleBMM, an Education Modules group, and a Cognitive Behavioural Therapy group. In total, 20 people started the study (14 in TeleBMM, 6 in Education Modules, and nobody was enrolled in the third group). Of those, 9 people completed the study (7 from TeleBMM and 2 from Education Modules), while 11 did not finish. The reported data shows that the main thing the study was measuring was whether the TeleBMM programme was practical and acceptable to participants. On average, TeleBMM participants completed 14.2 out of 20 programme components. For the satisfaction measure, no numbers were reported in the submitted data. For the secondary outcomes, the study tracked changes in migraine-related quality of life (using a questionnaire scored from 0 to 100, where higher scores mean better quality of life) and headache frequency. The reported data shows the TeleBMM group's quality-of-life score increased by an average of 9.3 points from the start of the study, while the Education Modules group's score decreased by an average of 11.4 points. For headache frequency, both groups' results were reported as a proportion of headache days per month — TeleBMM showed a change of 0.13 and the Education Control group showed a change of 0.18, though the direction of these changes was not further explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03592329 · results posted 25 February 2026

According to the results reported on ClinicalTrials.gov, this trial looked at people with migraines and a group of healthy volunteers. A total of 136 people started the study across five groups: two groups received active transcutaneous vagus nerve stimulation (tVNS — a mild electrical stimulation applied to the ear) combined with either mindfulness-based stress reduction (MBSR) or a non-emotional control programme (NEC); two groups received a sham (inactive) version of the same stimulation paired with the same programmes; and one group of healthy volunteers was included for comparison. Of those who started, 104 people completed the study — dropout numbers ranged from 5 to 10 across the different groups. The reported data shows two primary (main) outcomes, both related to brain measurements taken by scanning. The first looked at changes in brain activity in a region called the insula in response to facial stimulation, measured as a ratio of brain signals before and after treatment. The reported changes were: −0.249 for active tVNS + MBSR, +0.679 for active tVNS + NEC, +0.680 for sham tVNS + MBSR, and +1.06 for sham tVNS + NEC. The second primary outcome measured a marker related to brain inflammation in the insula using a specialised scan; changes from before to after treatment were: −0.007 for active tVNS + MBSR, −0.011 for active tVNS + NEC, +0.059 for sham tVNS + MBSR, and −0.023 for sham tVNS + NEC. For comparison at the start of the study, the reported inflammation marker reading was 0.974 in healthy controls and 0.989 in migraine patients, and a measure of brain activity during a stress-imagery task was −0.114 in healthy controls and +0.015 in migraine patients. The reported data also shows scores from two questionnaires. On the Headache Impact Test (scored 36–78, where higher means greater impact on daily life), changes from before to after treatment were: −5.05 for active tVNS + MBSR, −1.17 for active tVNS + NEC, −2.60 for sham tVNS + MBSR, and −3.61 for sham tVNS + NEC — all groups showed a decrease. On the Pain Catastrophizing Scale (scored 0–52, where higher means greater distress around pain), changes were: −5.26 for active tVNS + MBSR, −1.48 for active tVNS + NEC, −0.47 for sham tVNS + MBSR, and −3.94 for sham tVNS + NEC. These numbers reflect what was recorded in this trial only, and no conclusions about whether any differences between groups are meaningful can be drawn from the raw figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT06874361 · results posted 10 February 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 156 people in total — 77 in the active treatment group and 79 in the sham (inactive/placebo-style) group. Of those, 61 and 64 respectively completed the study. The trial was measuring whether the active treatment could reduce migraine headache pain and related symptoms compared to a sham version of the same treatment, looking at outcomes at 2 hours and 24 hours after treatment. The reported data shows that for the main outcome — being completely free of pain at 2 hours — 15 participants in the active treatment group and 14 in the sham group reached that result. For the secondary outcomes: freedom from the participant's most bothersome symptom (such as nausea or light sensitivity) at 2 hours was reported in 21 active and 26 sham participants; sustained pain freedom at 24 hours was reported in 8 active and 11 sham participants; and meaningful pain relief (not necessarily complete freedom) at 2 hours was reported in 35 active and 38 sham participants. When participants rated their own overall impression of how much they felt improved (on a 7-point scale, with 1–2 counted as a clear improvement), 20 active and 32 sham participants fell into that category. A separate set of figures in the same measure showed 41 active and 32 sham participants, though the distinction between these two sets of numbers was not fully explained in the reported data. Use of rescue medication before the 2-hour mark was reported for 5 active and 3 sham participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05028569 · results posted 9 December 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05028569) looked at two different doses of BOTOX (155 units and 195 units) compared to a dummy injection (placebo) in people with migraine. A total of 775 people entered the initial screening phase, and 775 were then split into three groups for the main double-blind phase — meaning neither the participants nor the researchers knew who was receiving which treatment. The trial was primarily measuring how the number of migraine days per month changed over months 5 and 6 of the study, and also tracked adverse events (unwanted medical occurrences that happened during the trial). The reported data shows that, on average, all three groups had a reduction in monthly migraine days of around 3 days compared to where they started — specifically minus 3.0 days for the placebo group, minus 3.1 days for the 155-unit BOTOX group, and minus 3.0 days for the 195-unit BOTOX group. For the secondary outcomes, the reported data shows similarly close results across all three groups: reductions in monthly headache days ranged from about 2.9 to 3.2 days; roughly 45–47% of participants in each group had their migraine days cut by at least half; reductions in days using acute headache medications were around 1.8 to 2.0 days per month; and improvements in a quality-of-life score (measuring how migraines limited daily and work activities, on a 0–100 scale) were between 18.6 and 19.4 points across all groups. Regarding adverse events, the reported data shows that during the double-blind phase, unwanted medical occurrences were reported in 106 participants in the placebo group, 117 in the 155-unit group, and 120 in the 195-unit group; serious adverse events were reported in 6, 3, and 6 participants respectively in those same groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05452239 · results posted 4 December 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled around 608 participants (approximately 305 in the eptinezumab group and 303 in the placebo group). The trial was looking at people with chronic migraine and was measuring changes in the number of migraine days per month over a placebo-controlled period, followed by an open-label period where everyone received the active treatment. The main thing being tracked was how many migraine days per month participants experienced compared to where they started. The reported data shows that, for the primary outcome — change in migraine days per month over the first four weeks — the eptinezumab group reported a reduction of about 6.85 days per month, while the placebo group reported a reduction of about 3.66 days per month. Over the full 12-week placebo-controlled period, the reported reductions were 7.44 days per month for the eptinezumab group and 4.50 days per month for the placebo group. The reported data also shows that around 37.8% of the eptinezumab group (compared to 18.1% in the placebo group) no longer met the clinical criteria for chronic migraine or medication overuse headache at weeks 1–4, with similar patterns reported at weeks 1–12. Reductions in general headache days per month and in days using acute migraine medications were also reported for both groups, with larger reductions seen in the eptinezumab group across all these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT01899040 · results posted 31 May 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT01899040) enrolled 100 people in total across three groups: 50 used an active device, 30 used a fully inactive placebo device, and 20 used a partially active placebo device. The trial was measuring whether using the device affected the number of days per month that participants experienced migraines, as well as a range of other measures including headache pain scores, mood, balance, and mental processing speed. By the end of the study, 42, 22, and 17 participants completed the trial in each of the three groups respectively. The reported data shows that, for the primary measure — the change in the number of migraine days per month after three months — participants using the active device reported an average reduction of 3.5 migraine days per month, compared to an average reduction of 1.1 days per month in the fully inactive placebo group. For one of the secondary measures, 20 out of the active device participants reported a reduction of 50% or more in their monthly migraine days, compared to 6 participants in the fully inactive placebo group. The reported data also shows a reduction in the monthly headache pain score (a running total of daily pain ratings out of 10) of 19.3 points in the active device group, compared to 10.3 points in the placebo group. For the safety-related measures, the reported data shows that mood scores (measured using a standard depression questionnaire) improved slightly across all three groups, with changes of -0.7, -0.9, and -0.9 respectively — all small shifts on a scale of 0 to 63. Balance test scores showed no meaningful change in any group, with scores of 0.0, 0.0, and 0.3 on a scale of 0 to 56. Mental processing speed (measured by a symbol-matching task) showed small improvements across all groups, with average increases of 7.1, 5.0, and 7.4 additional correct matches completed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT03706794 · results posted 6 April 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03706794) involved 18 people in total — 8 in a group that used a Clinical Decision Support Tool and 10 in a group that received Headache Education. All 18 participants completed the study. The trial was measuring how well people with migraines stuck to recommended management strategies, such as taking migraine medication early (while pain was still mild), avoiding overuse of medication, following behavioural strategies like managing stress, sleep, and eating habits, and taking any prescribed preventive medication consistently. The reported data shows that at the six-month mark, no participants in the Clinical Decision Support Tool group and 2 participants in the Headache Education group took their migraine medication early (at the mild pain stage). Regarding medication overuse, no participants in the Clinical Decision Support Tool group and 1 participant in the Headache Education group met the definition of overuse. For behavioural strategies — such as managing stress, sleep, or eating — the Clinical Decision Support Tool group recorded an average of 10.1 adherent days per month, while the Headache Education group recorded 0.0 days. For preventive medication (among those who were taking it), the Clinical Decision Support Tool group averaged 15.0 adherent days per month compared to 12.3 days in the Headache Education group. The reported data also shows secondary measurements at six months. The median number of headache days per month was 3.4 for the Clinical Decision Support Tool group and 4.4 for the Headache Education group. Headache pain intensity, rated on a scale of 0 (no pain) to 10 (worst pain imaginable), had a median score of 5.0 in the Clinical Decision Support Tool group and 6.0 in the Headache Education group. It is worth noting that with only 8 to 10 people per group, this was a very small study, so these figures should be interpreted with that in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03381261 · results posted 24 March 2025

According to the results reported on ClinicalTrials.gov, this trial involved 37 people who experience chronic migraines on both sides of their head. The trial used a "split-person" design, meaning each participant served as their own comparison — one side of their head received an injection of onabotulinumtoxin A (a medication sometimes used for migraines), while the other side received no injection. Tissue samples were then collected from both sides during a separate migraine-related surgery the participants were already scheduled to have. The samples were analysed to look at the activity of 594 genes related to inflammation and the immune system. The reported data shows that, on average, the treated side of the head had a measured gene expression level of approximately 44.5 mRNA units (mRNA units are a way of measuring how active certain genes are), while the untreated side had a measured gene expression level of approximately 68.7 mRNA units. These figures represent the activity of inflammatory genes in tissue taken from each side. Of the 37 people who started the study, 31 completed the first phase and 18 completed the full analysis phase; the reasons for the remaining participants not completing were not detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05264129 · results posted 8 October 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT05264129) involved 262 participants and was set up in two back-to-back phases. In the first phase (weeks 1–12), all 262 participants took a daily preventive migraine tablet called atogepant (60 mg); 221 of them completed this phase. In the second phase (weeks 12–24), 218 of those participants moved on to take atogepant together with a separate migraine tablet called ubrogepant (100 mg), and 203 of them completed that phase. The trial's primary focus was on monitoring and recording safety-related information — specifically adverse events (unexpected medical occurrences), laboratory test results, heart tracings (ECGs), vital signs such as blood pressure and pulse, and any reports of suicidal thoughts or behaviours. The reported data shows that during the first phase (atogepant alone), 130 out of 262 participants experienced at least one adverse event — an unexpected medical occurrence that arose during the study period. During the second phase (atogepant plus ubrogepant), 94 out of 218 participants experienced at least one such event. For laboratory tests, ECGs, and vital signs, the reported data shows that only small numbers of participants had readings flagged as "potentially clinically significant" (meaning notably outside normal ranges) in either phase — typically between 0 and 7 participants across the various categories measured. Regarding suicidal thoughts and behaviours, which were tracked using a structured rating scale called the C-SSRS, the reported data shows that during the first phase no participants reported suicidal thoughts or behaviours, while during the second phase 2 participants reported suicidal thoughts and 1 reported suicidal behaviour. During a four-week follow-up period after the trial ended, 1 participant reported suicidal thoughts and none reported suicidal behaviour. No secondary outcome measures appear to have been reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04613362 · results posted 19 September 2024

According to the results reported on ClinicalTrials.gov, this trial (known as TENACITY) involved 57 people in total — 30 in a group that received a telehealth version of Cognitive Behavioural Therapy (a talking-based approach to managing thoughts and behaviours) specifically designed for migraine, and 27 in a comparison group who received what the trial called "behavioural usual care." The trial was measuring two main things: the number of headache days participants experienced at three months, and the costs involved in setting up and running each program. It also tracked several other measures, including how migraines affected quality of life and daily activities, how participants thought about their headache pain, and how confident they felt in managing their headaches. The reported data shows that, for the main headache-day measure, the telehealth therapy group started with an average of about 18 headache days and reported around 16 days at the three-month point. The usual care group started at roughly 19 days and reported about 18 days at three months. On the cost side, the reported data shows the telehealth therapy program cost approximately $12,021 to implement, compared with around $272 for the usual care program. For the other measures — quality of life, disability, catastrophic thinking about pain, and confidence in managing headaches — the reported data shows scores for both groups at the start and at follow-up, but the differences between groups were generally small; detailed breakdowns were not provided beyond the group averages reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT05127486 · results posted 18 June 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT05127486) enrolled 580 adults in total — 287 in the galcanezumab group and 293 in the rimegepant group — all of whom received at least one dose of their assigned study drug. The trial ran for three months and was primarily measuring the proportion of participants whose monthly migraine headache days fell by at least half compared to where they started (called a "50% response rate"). A number of secondary measures were also tracked, including larger reductions in migraine days and month-by-month changes. The reported data shows that, averaged across the three-month period, approximately 62% of participants in the galcanezumab group and 61% in the rimegepant group met that primary "50% response" threshold. For the secondary measures, the reported data shows that around 37% of the galcanezumab group and 33% of the rimegepant group achieved a 75% reduction in monthly migraine days, while 18% and 15% respectively achieved a 100% reduction (meaning no migraine days at all in that period). In terms of the actual number of days, participants in the galcanezumab group reported an average reduction of about 4.75 migraine days per month across the three months, compared with about 4.39 days per month for the rimegepant group. Month-by-month figures were also reported: in Month 1, reductions were approximately 4.33 days (galcanezumab) and 3.77 days (rimegepant); in Month 2, approximately 4.81 days and 4.44 days respectively. Month 3 figures were not reported separately in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04498910 · results posted 28 November 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04498910) enrolled 38 people in total — 19 received a drug called LY3451838 (at a dose of 1,500 mg) and 19 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in the number of days per month that participants experienced migraine headaches, comparing those who received the study drug against those who received the placebo. The reported data shows that, over a one-month period (the main thing the trial was set up to measure), people in the LY3451838 group reported an average reduction of 3.8 migraine days per month from their starting point, while those in the placebo group reported an average reduction of 2.7 days per month. Over a three-month period, the reported reductions were 3.6 days per month for the LY3451838 group and 2.2 days per month for the placebo group. When looking at how many participants had their migraine days cut by at least half, the reported data shows 21.1% in the LY3451838 group and 26.3% in the placebo group achieved this. Regarding unwanted health events that occurred during the trial, 11 out of 19 participants in the LY3451838 group and 13 out of 19 in the placebo group experienced at least one such event. One participant in the LY3451838 group and none in the placebo group experienced a serious unwanted health event. It is worth noting that this was a small trial — only 19 people per group — and results from small studies can be less reliable than those from larger ones. Not all participants completed the study: 3 people in the LY3451838 group and 2 in the placebo group did not finish. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03150797 · results posted 13 October 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03150797) looked at whether melatonin could reduce the number of migraine or migraine-like headache days in children and adolescents. The trial had two phases. First, 72 participants went through a single-blind run-in phase (where everyone received a placebo, meaning a dummy pill), and 59 of them completed it. Then 42 participants moved into the main double-blind phase — 14 in each group: melatonin 3mg, melatonin 6mg, and placebo. In the double-blind phase (where neither participants nor researchers knew who was getting which treatment), 10 in the melatonin 3mg group, 10 in the melatonin 6mg group, and 7 in the placebo group completed the study. The reported data shows that the primary outcome — the number of migraine or migraine-like days during weeks 5 to 8 of the main treatment phase — was a median (meaning the middle value when all results are lined up in order) of 2 days for all three groups: melatonin 3mg, melatonin 6mg, and placebo. The secondary outcomes comparing the groups to each other also returned a median of 2 days across all groups. When looking at the change in headache days from the earlier placebo run-in phase to weeks 5–8 of the main phase, the reported data shows a change of 2 days for the melatonin 3mg group, minus 1 day for the melatonin 6mg group, and 0 days for the placebo group. The disability score (PedMIDAS) was listed as a secondary outcome, but no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03971071 · results posted 13 October 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03971071) looked at erenumab — a preventive migraine injection — in people who were overusing acute headache medications (a condition sometimes called "medication overuse headache," or MOH). A total of 620 adults took part in the main double-blind phase, split roughly equally into three groups: one receiving a placebo (dummy injection), one receiving a 70 mg dose of erenumab, and one receiving a 140 mg dose. Participants were tracked over six months to see whether their pattern of medication use changed. After the double-blind phase, 587 participants continued into an open-label phase where everyone received erenumab. The primary thing the trial measured was how many participants no longer met the criteria for medication overuse headache by the end of month six. The reported data shows that, out of roughly 206–207 people per group, 102 in the placebo group, 117 in the 70 mg group, and 134 in the 140 mg group reached that point. The trial also measured how many days per month participants used acute headache medications. The reported data shows average reductions of about 6.6 days per month for the placebo group, 7.8 days for the 70 mg group, and 9.4 days for the 140 mg group, compared to where each group started. On a separate measure — sustained remission from medication overuse headache at both the three-month and six-month marks — the reported figures were 73 participants in the placebo group, 96 in the 70 mg group, and 119 in the 140 mg group. The trial also tracked participants' scores on a questionnaire about how migraines affected their physical functioning and everyday activities (scored 0–100, where higher means greater burden). The reported data shows reductions in physical impairment scores of about 8.5 points (placebo), 11.8 points (70 mg), and 10.6 points (140 mg), and reductions in everyday activity impact scores of about 10.9 points (placebo), 13.5 points (70 mg), and 13.3 points (140 mg). Regarding unwanted events during the trial, the reported data shows that 130 out of 206 placebo participants, 139 out of 207 in the 70 mg group, and 142 out of 207 in the 140 mg group experienced at least one treatment-emergent adverse event during the double-blind phase; in the open-label phase, 178 out of 291 in the 70 mg group and 182 out of 296 in the 140 mg group did so. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04936061 · results posted 29 September 2023

According to the results reported on ClinicalTrials.gov, this trial tested a device called CoolStat on 24 people with migraine headaches. Participants were split into three groups: 6 people received a high-flow treatment, 9 received a low-flow treatment, and 9 received a sham (dummy) treatment using ordinary ambient air. All 24 participants completed the study. The trial was measuring how many people experienced pain relief two hours after using the device, as well as how well participants tolerated the device and how many experienced device-related unwanted events. The reported data shows that for the main pain relief measure at two hours, 3 out of 6 people in the high-flow group, 4 out of 9 in the low-flow group, and 8 out of 9 in the sham (ambient air) group went from a moderate or severe headache down to a mild or no headache. For tolerability, 2 people in the high-flow group and 1 person in the low-flow group did not complete the full treatment session, while everyone in the sham group did. Regarding device-related unwanted events, 3 participants in the high-flow group and 3 in the low-flow group had such events reported, compared to none in the sham group. The reported data also shows secondary (additional) results: immediately after treatment, 0 high-flow, 3 low-flow, and 7 sham participants had pain relief; at 24 hours without extra medication, the numbers were 1, 2, and 5 respectively. For complete freedom from headache pain at two hours (without extra medication), 0 participants in either active treatment group reached this point, compared to 4 in the sham group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04740827 · results posted 21 September 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04740827) enrolled 158 people in the placebo group and 157 people in the atogepant 60 mg group, for a total of 315 participants. The trial ran for 12 weeks and was measuring whether a daily tablet called atogepant (60 mg) reduced the number of days per month that people experienced migraines and headaches, compared with a placebo (a dummy tablet with no active ingredient). Participants kept a daily diary to record their migraine and headache days throughout the study. The reported data shows that, at the start of the trial, both groups had a similar number of migraine days per month. Over the 12-week treatment period, the placebo group reported a reduction of approximately 1.86 migraine days per month on average, while the atogepant group reported a reduction of approximately 4.29 migraine days per month on average. A similar pattern was seen for general headache days: the placebo group reported a reduction of about 1.93 headache days per month, compared with about 4.21 days per month in the atogepant group. The reported data also shows that, when looking at participants who recorded at least a 50% drop in their monthly migraine days across the 12 weeks, 27 out of 154 people in the placebo group reached that level, compared with 77 out of 151 people in the atogepant group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03338920 · results posted 24 July 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03338920) enrolled 159 people who experienced migraines — 79 were given a sumatriptan nasal powder and 80 received a placebo (a dummy treatment with no active ingredient). The trial was measuring how many participants reported being completely free of headache pain two hours after taking their assigned treatment. Most participants completed the study — 75 in the sumatriptan group and 74 in the placebo group. The reported data shows that at the two-hour mark, 8 out of 79 participants in the sumatriptan nasal powder group reported being headache pain free, compared with 9 out of 80 participants in the placebo group. No other outcome measures were included in the structured results data submitted, so figures for any secondary outcomes are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04940390 · results posted 24 July 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04940390) enrolled a total of 1,591 participants — 796 in the STS101 5.2 mg group and 795 in the placebo group (a placebo is a dummy treatment with no active ingredient, used for comparison). The trial was measuring how people with migraine responded two hours after taking either STS101 or the placebo, looking specifically at pain levels and troublesome symptoms like sensitivity to light, sensitivity to sound, and nausea. The reported data shows that for the first main outcome — complete freedom from migraine headache pain at two hours — 146 participants in the STS101 group and 124 participants in the placebo group reported no pain. For the second main outcome — freedom from the single most bothersome symptom at two hours — 265 participants in the STS101 group and 230 in the placebo group reported being free of that symptom. As a secondary (additional) measure, pain relief at two hours (meaning pain dropped from moderate or severe down to mild or none) was reported by 379 participants in the STS101 group and 316 in the placebo group. It is worth noting that the data was submitted as raw participant counts rather than percentages, even though the outcome titles refer to percentages, so the full percentage figures were not separately reported in the structured data available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04406649 · results posted 3 July 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04406649) enrolled 482 people, all of whom received a treatment called STS101 at a dose of 5.2 mg. Of those who started, 205 completed the study and 277 did not complete it. The trial was measuring two main things during migraine attacks: first, whether participants became completely free of head pain and stayed that way from 2 hours up to 48 hours after taking the treatment; and second, whether their single most bothersome migraine symptom — chosen from nausea, sensitivity to light, or sensitivity to sound — also went away and stayed away over that same 2- to 48-hour window. The reported data shows that, looking at the group of participants included in the main analysis, 40% of attacks were associated with participants going from moderate or severe head pain all the way down to no pain at all, and remaining pain-free through to the 48-hour mark. For the most bothersome symptom, the reported data shows that 60% of attacks were associated with that symptom being gone and staying gone over the same 2- to 48-hour period. It is worth noting that there was no comparison group (such as a placebo or dummy treatment group) reported in this data, so these figures reflect only the single treatment group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03901482 · results posted 29 June 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,201 people across three groups: those who received a low dose of STS101 (399 people), a high dose of STS101 (400 people), or a placebo — a dummy treatment with no active ingredient (402 people). The trial was measuring how STS101, a treatment for migraine, performed against placebo two hours after a single dose was taken during a migraine attack. Around 363–368 people in each group completed the study. The reported data shows two main things were measured at two hours after taking the dose. The first was "pain freedom" — meaning a person's pain went from moderate or severe all the way down to no pain at all. The numbers reported were 69 participants in the low-dose group, 68 in the high-dose group, and 53 in the placebo group who reached this outcome. The second main measure was freedom from the single most bothersome symptom (such as sensitivity to light, sensitivity to sound, or nausea): 133 people in the low-dose group, 139 in the high-dose group, and 119 in the placebo group reported this outcome. A secondary measure looked at "pain relief" — a broader result where pain dropped to mild or no pain — with 180, 177, and 166 participants reporting this in the low-dose, high-dose, and placebo groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00812214 · results posted 15 June 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 79 people in total — 38 received a 3 mg dose of eszopiclone (a sleep medication) and 41 received a placebo (a dummy pill with no active ingredient). The trial was looking at how the two groups compared on sleep-related measures, including how long people slept each night, how often they woke up, their self-rated sleep quality, daytime alertness and fatigue, and how frequently they had headaches. Participants kept a daily diary throughout the study, and their responses were averaged over the six-week treatment period. The reported data shows that, at the start of the study (baseline), both groups were sleeping a similar amount — around 5.4–5.5 hours per night on average. By the end of the six-week period, the eszopiclone group reported an average of 6.3 hours of sleep per night, while the placebo group reported 6.1 hours. For nighttime awakenings, the eszopiclone group started at an average of 2.4 per night and ended at 1.5, while the placebo group went from 2.7 to 2.2. On sleep quality (rated 1–10, where 10 is excellent), the eszopiclone group moved from 5.1 to 6.7, and the placebo group from 4.9 to 6.2. Daytime fatigue scores (1–10, where 10 is extremely tired) were reported as 4.3 for the eszopiclone group and 5.0 for the placebo group at the end of the study. Headache frequency was reported at 2.5 days per week for both groups by the end of the trial — down slightly from around 2.9–3.1 days per week at baseline for each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04492020 · results posted 31 May 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04492020) enrolled 518 adults across two treatment sequences (264 in Sequence A and 254 in Sequence B). The trial was a crossover study, meaning participants took both a placebo and ubrogepant 100 mg (a migraine medicine) at different points, during the early warning phase of a migraine — before a headache fully develops. The main thing the trial was measuring was whether participants avoided a moderate or severe headache in the 24 hours after taking the study treatment during that early warning phase. The reported data shows that for the primary measure — avoiding a moderate or severe headache within 24 hours — 190 participants reported this outcome after taking ubrogepant 100 mg, compared with 121 participants after taking placebo. For the first secondary measure, looking at the same outcome but over 48 hours, 159 participants reported avoiding a moderate or severe headache with ubrogepant, compared with 100 on placebo. The reported data also shows that for avoiding a headache of any intensity within 24 hours, 103 participants reported this after ubrogepant compared with 61 after placebo. The remaining secondary measure tracked how well participants felt they could function normally over 24 hours using a rating scale; multiple counts were reported across different time points, though the data as submitted does not include the percentage figures needed to fully interpret those numbers. It is worth noting that because this was a crossover trial, the participant counts reported across outcomes reflect the number of treatment periods rather than unique individuals, and some figures — such as exact percentages for the functioning measure — were not fully reported in the structured data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04829747 · results posted 24 May 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04829747) enrolled 3 participants, all of whom received the study drug, atogepant. Two participants completed the trial and one did not. The trial was primarily focused on monitoring participants for any medical events or changes in their health measurements — specifically looking at adverse events (unexpected medical occurrences), blood and laboratory test results, vital signs such as blood pressure and pulse, heart tracings (ECGs), and any changes in thoughts of self-harm assessed using a standard rating scale. The reported data shows that, out of the 3 participants, 1 experienced an adverse event — meaning an unexpected medical occurrence was recorded during the study period. The reported data shows that 0 participants had a notable change in their laboratory blood test results, 0 had a meaningful change in their vital signs, 0 had a meaningful change in their heart tracing (ECG) results, and 0 showed any change on the self-harm thoughts rating scale. No further detail about the nature of the one adverse event was included in the submitted results data. It is worth noting that this was a very small trial with only 3 participants, and the results data as submitted does not include any broader effectiveness measurements. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04698525 · results posted 17 May 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 33 people in total — 17 in the valproate group and 16 in the memantine group — to compare two medications used to try to prevent episodic migraine (migraines that occur on a limited number of days per month). The trial ran for three months and measured three main things before and after treatment: how many days per month participants experienced migraine, how painful those migraines were (rated on a 0–10 scale where 0 means no pain and 10 means the worst imaginable pain), and how much migraines were affecting daily life (using a scoring tool called the MIDAS scale, where higher numbers mean greater disruption). By the end of the study, 14 people in the valproate group and 13 in the memantine group completed the trial. The reported data shows the following changes in average scores from before to after treatment. For migraine days per month, the valproate group went from an average of 5.35 days down to 0.77 days, and the memantine group went from 5.31 days down to 0.93 days. For pain intensity, the valproate group's average score went from 8.94 down to 2.5, while the memantine group went from 8.50 down to 4.28. For the MIDAS disability scale (scored 0–70, where above 20 indicates significant daily limitations), the valproate group's average went from 51.92 down to 10.53, and the memantine group's went from 60.87 down to 15.57. For weight — a secondary measure — the reported averages were largely similar before and after in both groups (valproate: 71.77 kg to 72.13 kg; memantine: 64.44 kg to 64.19 kg). Regarding side effects, the data reports that 6 participants in the valproate group and 4 in the memantine group experienced some form of side effect, with no life-threatening or serious side effects reported in either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03855137 · results posted 14 February 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03855137) enrolled 778 people across three groups: 259 received a placebo (a dummy pill with no active ingredient), 257 received atogepant 30 mg twice daily, and 262 received atogepant 60 mg once daily. The trial ran for 12 weeks and was measuring changes in the number of migraine days per month, headache days per month, and the number of days per month that participants took acute (rescue) medication for their migraines. Participants kept a daily diary to record this information. The reported data shows that, on average, all three groups experienced a reduction in monthly migraine days compared to where they started (a negative number means fewer migraine days). For the placebo group, the reported average reduction was approximately 4.6 migraine days per month. For the atogepant 30 mg twice-daily group, the reported reduction was approximately 7.1 days per month, and for the atogepant 60 mg once-daily group it was approximately 7.3 days per month. A similar pattern was reported for monthly headache days: the placebo group saw a reduction of around 4.3 days, while the two atogepant groups saw reductions of around 7.2 and 6.7 days respectively. For days per month taking acute migraine medication, the placebo group reported a reduction of roughly 3.6 days, compared to approximately 6.2 and 6.3 days for the two atogepant groups. It is worth noting that all three groups showed a reduction from their starting point, including the placebo group — this is a commonly observed pattern in clinical trials. The trial also included a follow-up period from week 12 to week 16, though the reported outcome numbers above cover only the 12-week treatment period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04341298 · results posted 9 January 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 78 people in total — 38 who used the Avulux® lens device and 40 who used a control (sham) device that looked similar but was not the same. All 78 participants completed the trial with no drop-outs. The trial was measuring changes in migraine pain during severe headache attacks, using an 11-point pain scale where 0 means no pain and 10 means the worst pain imaginable. Participants wore their assigned device during a migraine and reported their pain scores at different time points. The reported data shows that two hours after putting on the device during a severe migraine, the Avulux® group's pain scores dropped by an average of 1.42 points, while the control group's scores dropped by an average of 1.14 points. At four hours, the Avulux® group showed an average drop of 2.67 points and the control group showed an average drop of 2.80 points. For the additional pre-specified measures, 2 people in the Avulux® group and 4 in the control group went from severe pain down to mild or no pain within two hours. Eleven participants in each group needed rescue medication within eight hours. Regarding light sensitivity at two hours, 9 people in the Avulux® group reported it compared with 16 in the control group; at four hours, those numbers were 7 and 10 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02720211 · results posted 29 November 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT02720211) involved 10 people in total — split evenly into two groups of 5. One group wore grey tinted spectacle lenses and the other wore thin-film spectacle lenses. All 10 participants completed the study with no drop-outs. The trial was measuring two things: how often participants experienced headaches over a month, and how much those headaches affected their daily life. The reported data shows that, on average, the group wearing grey tinted lenses recorded 12 days per month with a headache lasting at least 4 hours, compared to 15 days per month in the thin-film lenses group. For the second measure — the impact of headaches on daily life — participants used a standard questionnaire called the HIT-6, where scores range from 36 to 78 and higher scores mean a bigger impact on daily life. The grey tinted lenses group had an average score of 50 (described by the scale as "some impact"), while the thin-film lenses group had an average score of 55 (also in the "some impact" range, though closer to the "substantial impact" category). It is worth noting that with only 5 people in each group, these numbers reflect a very small sample. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03096834 · results posted 18 February 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03096834) enrolled 246 adults with migraines — 121 received a monthly injection of AMG 334 (erenumab) at a dose of 140 mg, and 125 received a placebo (an inactive injection). The trial was measuring changes in migraine days over roughly three months, with the main question being: how many people had their monthly migraine days cut in half or more by the last four weeks of treatment? The reported data shows that for the primary measure — the proportion of people whose migraine days dropped by at least 50% — 30.3% of those in the AMG 334 group reached that threshold, compared with 13.7% in the placebo group. For secondary measures, the average change in monthly migraine days by the final four weeks was reported as a reduction of 1.75 days in the AMG 334 group, versus a reduction of 0.16 days in the placebo group. The reported data also shows that 11.8% of the AMG 334 group had their migraine days reduced by at least 75%, compared with 4.0% in the placebo group; and 5.9% of the AMG 334 group reported no migraine days at all in the last four weeks, compared with 0% in the placebo group. The number of days per month participants used specific migraine medications (such as triptans) fell by an average of 1.25 days in the AMG 334 group, compared with an increase of 0.46 days in the placebo group. Scores measuring how migraines affected physical function and everyday activities also showed reported differences between the two groups, with the AMG 334 group recording reductions in those burden scores while the placebo group recorded small increases, though the specific numbers for each sub-score were not fully separated in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02025556 · results posted 24 January 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 297 adults across three groups: 104 received a placebo (a dummy treatment with no active ingredient), 96 received a low dose of the study treatment, and 97 received a high dose. The trial was measuring changes in the number of migraine days per month over a 12-week period, as well as tracking any unwanted medical events (called adverse events) that occurred during the study. The reported data shows that, on average, participants in the placebo group experienced approximately 3.5 fewer migraine days per month by the end of the 12-week period compared to when they started. In the low-dose group, the reported reduction was around 6.3 fewer migraine days, and in the high-dose group it was around 6.1 fewer migraine days. For headache days of any severity (not just migraines), the reported reductions were similar: approximately 3.5 days fewer in the placebo group, 6.1 days fewer in the low-dose group, and 6.1 days fewer in the high-dose group. Regarding adverse events, 58 placebo participants, 44 low-dose participants, and 57 high-dose participants reported experiencing at least one adverse event during the study. Most adverse events were rated as mild or moderate across all three groups, with very few rated as severe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02358681 · results posted 12 January 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 59 children or young people in total — 29 received ketorolac (a pain-relief medicine) as a nasal spray, and 30 received it through a drip into a vein (intravenously). The trial was measuring how much pain scores changed after receiving the medicine, using a recognised pain rating tool called the Faces Pain Scale – Revised (FPS-R), which runs from 0 (no pain) to 10 (the worst possible pain). The reported data shows that, at 60 minutes after receiving the medicine, the average drop in pain score was 4.2 points in the nasal spray group and 4.4 points in the intravenous group. For a secondary measure — how long it took for pain scores to fall by at least 2 points out of 10 (considered a meaningful reduction) — the reported average was about 21.9 minutes for the nasal spray group and 18.6 minutes for the intravenous group. The reported data also shows that 25 out of 27 participants who completed the study in the nasal spray group, and 26 out of 29 in the intravenous group, experienced what the trial defined as headache relief (pain going from severe or moderate down to mild or none, without needing extra pain medicine). Eleven participants in the nasal spray group and 17 in the intravenous group were reported to have become completely pain-free without needing extra medicine. Six participants in the nasal spray group and five in the intravenous group did need additional pain medicine during their visit. Regarding adverse events (unwanted side effects), zero participants in the nasal spray group and one participant in the intravenous group were reported to have experienced one. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02021773 · results posted 1 November 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 264 adults across three groups: 89 received a placebo (a dummy treatment with no active ingredient), 88 received a low dose of a medicine called LBR-101, and 87 received a high dose of LBR-101. The trial was looking at a treatment being investigated for migraine prevention. The main things being measured were: how the total number of hours per month that participants spent with a headache (of any severity) changed over the course of the study, and how many participants experienced at least one unwanted medical event (called an adverse event) during the trial. A secondary measure tracked how the number of days per month with at least a moderate headache changed. The reported data shows that, when looking at the change in monthly headache hours from the start of the study to the 12-week mark, all three groups recorded a reduction. The placebo group's average reduction was about 37 hours per month, the low-dose LBR-101 group recorded an average reduction of about 60 hours per month, and the high-dose LBR-101 group recorded an average reduction of about 68 hours per month. Regarding unwanted medical events, the reported data shows that 36 out of 89 placebo participants, 47 out of 88 low-dose participants, and 41 out of 86 high-dose participants experienced at least one such event during the trial. For the secondary measure — days with at least moderate headache — the reported average reductions per month were approximately 4.2 days for the placebo group, 6.0 days for the low-dose group, and 6.2 days for the high-dose group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03521193 · results posted 19 October 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled two groups of participants: 78 people who had both a patent foramen ovale (PFO — a small natural opening in the heart that did not close properly after birth) and migraines, and 12 healthy volunteers who took aspirin. Of the 78 PFO and migraine patients, 62 completed the study, while 16 did not finish. The trial was measuring changes in migraine patterns after PFO closure (a procedure to seal the heart opening), as well as looking at how active platelets (tiny blood cells involved in clotting) were in both groups before and after the procedure. The reported data shows that, among the 62 PFO patients who completed the study and had their migraine response assessed, 43 were recorded as "full responders" (meaning their migraines appeared to stop completely), 17 were recorded as having a "moderate benefit," and 2 were recorded as "non-responders." For migraine severity, the trial used a scoring tool called Anzola's score (where higher numbers mean more severe migraines, on a scale from 2 to 9). The reported data shows the average score at the start of the study was 7.2, which fell to 1.09 at one point and 1.1 at another follow-up point — though the exact timing of those follow-up measurements was not fully described in the submitted data. Regarding the platelet activity measurements, the reported data shows a range of figures across the PFO patient group, the healthy volunteer group, and the PFO patients at six months after their procedure. For example, one measure of platelet activity (recorded in nmol/L) was reported as 115.2 in PFO patients at the start, 63.4 in healthy volunteers, and 77.2 in PFO patients at six months. The other platelet measures followed a similar pattern of different values across the three groups, though what these differences mean clinically was not explained in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03303105 · results posted 16 July 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03303105) involved 50 people in total, split evenly into two groups of 25. One group received a 225 mg monthly dose of TEV-48125, and the other received a 675 mg dose every three months. The trial was looking at how often participants experienced side effects after taking the study medication, and also tracked changes in the number of migraine days and moderate-to-severe headache days per month. The reported data shows that, for the primary measure — tracking how many participants had at least one side effect after starting treatment — 92% of people in the monthly 225 mg group and 88% of people in the three-monthly 675 mg group reported at least one such event. It is important to note that this was the main thing the trial was designed to measure; the specific nature of those side effects is listed separately in the trial's adverse events section, which is not included here. For the secondary measures, the reported data shows that participants in the 225 mg monthly group had, on average, 5.9 fewer migraine days per month compared to where they started, while the 675 mg three-monthly group had an average reduction of 1.6 days per month. For headache days rated as at least moderate in severity, the 225 mg monthly group reported an average reduction of 4.3 days per month, compared to 2.1 days per month in the 675 mg three-monthly group. These numbers reflect averages across each group and do not represent any individual's experience. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03777059 · results posted 9 July 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03777059) enrolled 910 adults with migraine, who were divided into four groups: one group received a placebo (a dummy pill with no active ingredient), and the other three groups received daily oral doses of a medicine called atogepant at either 10 mg, 30 mg, or 60 mg. The trial ran for 12 weeks of treatment, followed by a four-week follow-up period. The main thing being measured was the change in the average number of migraine days per month compared to each participant's starting level before the trial began. The reported data shows that, on average, participants in the placebo group experienced about 2.5 fewer migraine days per month over the 12-week period compared to their starting point. For the atogepant groups, the reported reductions were approximately 3.7 fewer days per month (10 mg), 3.9 fewer days per month (30 mg), and 4.2 fewer days per month (60 mg). The reported data also shows similar patterns for the secondary measures — including headache days, days using acute (quick-relief) migraine medications, and quality-of-life and daily activity scores — with all atogepant groups reporting larger reductions or improvements compared to the placebo group. For example, the proportion of participants whose average monthly migraine days dropped by at least 50% was reported as 29% in the placebo group, compared to approximately 56%, 59%, and 61% in the 10 mg, 30 mg, and 60 mg atogepant groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03303092 · results posted 8 July 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03303092) looked at a medication called TEV-48125 (also known as fremanezumab) for the prevention of migraine. A total of 357 people took part — 121 received three monthly doses of 225 mg, 119 received one higher dose of 675 mg followed by two placebo (dummy) injections, and 117 received placebo only throughout. Participants kept a daily electronic diary recording their headache days, severity, and any pain-relief medications they used. The main thing being measured was the change in the average number of migraine days per month over the 12 weeks after the first injection. The reported data shows that, on average, people in the three-equal-doses group had about 4.0 fewer migraine days per month compared to their starting point, and people in the single-higher-dose group had about 4.0 fewer days as well. The placebo group reported about 1.0 fewer migraine days per month on average. For one of the secondary measures — the proportion of people whose monthly migraine days dropped by at least half — the reported figures were approximately 41% in the three-equal-doses group, 45% in the single-higher-dose group, and 11% in the placebo group. The reported data also shows that days per month using acute (rescue) pain medications fell by around 3.3 days in both active treatment groups, compared with about 0.5 days in the placebo group. Other secondary measures reported include a disability questionnaire called MIDAS, where lower scores indicate less headache-related disruption to daily life. The reported data shows average score reductions of approximately 12.6 points in the three-equal-doses group, 12.6 points in the single-higher-dose group, and 7.4 points in the placebo group. A separate analysis looking only at participants who were not already taking other preventive migraine medicines showed similar patterns, with migraine day reductions of around 4.4 and 4.2 days per month in the two active groups, versus about 1.4 days in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03303079 · results posted 15 June 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03303079) enrolled 571 people across three groups to study an injectable medicine called TEV-48125 (also known as fremanezumab) for migraine prevention. One group (189 people) received a higher starting dose followed by two lower doses; a second group (191 people) received a single high dose followed by two dummy injections (placebo); and a third group (191 people) received placebo injections throughout. The main thing the trial was measuring was how much the number of moderate-to-severe headache days per month changed over 12 weeks compared to where each person started. The reported data shows that, on average, the two TEV-48125 groups had a reduction of about 4.1 moderate-to-severe headache days per month (both groups reported approximately −4.12 and −4.14 days/month respectively), while the placebo group reported a reduction of about 2.5 days per month (−2.45). For the secondary measures, the reported data shows average reductions in migraine days per month of −4.90 and −4.07 for the two TEV-48125 groups, compared with −2.79 for the placebo group. When looking at the proportion of participants whose moderate-to-severe headache days fell by at least half, the reported figures were approximately 29% in each TEV-48125 group, compared with about 13% in the placebo group. Days using acute headache medicines (pain-relief medications taken during an attack) also fell by roughly 3.7–3.9 days per month in the TEV-48125 groups versus about 2.4 days in the placebo group. A questionnaire measuring how much headaches disrupted daily life (the HIT-6 scale) showed average score reductions of around 8 points in both TEV-48125 groups and about 6.5 points in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03700320 · results posted 15 June 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03700320) enrolled 198 people in the standard oral migraine prevention medication group and 546 people in the atogepant 60 mg group, for a total of 744 participants. The trial was primarily focused on monitoring and recording any new or worsening medical events (called "treatment-emergent adverse events") that occurred after participants started taking their assigned medication. Secondary measurements included blood and urine test results, heart tracing (ECG) readings, physical checks such as blood pressure and pulse, and a standardised questionnaire to screen for thoughts of self-harm. The reported data shows that 78.6% of participants in the standard medication group and 67.0% in the atogepant group experienced at least one treatment-emergent adverse event during the study. For blood and urine tests, the percentages of participants whose results were judged by the investigator to be clinically noteworthy were broadly similar across both groups, generally ranging from 0% to about 3–4% depending on the specific test category. Heart tracing results flagged as significant were also low in both groups (each below 1%). For physical measurements such as blood pressure and body weight, the proportions with notable findings were again small and broadly comparable between groups, with body weight changes being the most commonly noted (13.8% in the standard medication group and 11.4% in the atogepant group). Regarding the self-harm screening tool, the reported data shows that 4 participants in the standard medication group reported the mildest category of suicidal thoughts (a wish to be dead), compared with none in the atogepant group; small numbers of participants across both groups reported other categories on the scale, with full details available in the trial record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03361423 · results posted 19 May 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03361423) looked at a device-based treatment for migraine headaches. A total of 126 people were assigned to use an active (real) device and 126 were assigned to use a sham (inactive, dummy) device — a common way to test whether any change is due to the device itself rather than simply the act of using it. Of those who started, 99 people in the active group and 103 in the sham group completed the trial. The reported data shows that for the main thing being measured — the share of participants whose migraine pain reduced (from severe or moderate down to mild or none, or from mild to none) within two hours of treatment, without taking any additional pain relief — 66% of people using the active device reported this reduction, compared with 40% using the sham device. For the secondary measures, 44% of the active group reported being free from their most bothersome accompanying symptom (such as nausea, light sensitivity, sound sensitivity, or skin sensitivity) at two hours, versus 22% in the sham group. When looking at both headache reduction and symptom relief together, 38% of the active group and 15% of the sham group reported both outcomes. Complete disappearance of pain at two hours was reported by 37% in the active group and 19% in the sham group. A separate measure looking at consistency across multiple treated attacks found that 51.3% of the active group and 38.1% of the sham group showed pain reduction in at least half of their treated attacks. The reported data also notes that 14 adverse events (unexpected or unwanted experiences) were recorded in the active device group and 9 in the sham group, though this data alone does not indicate what those events were or how serious they may have been. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04153409 · results posted 30 March 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT04153409) enrolled 21 people who experienced migraines — 10 in a group that received the investigational treatment LAT8881 first and then a placebo, and 11 in a group that received the placebo first and then LAT8881. A total of 17 participants completed the study, with 4 not completing it across both groups. The trial was measuring changes in migraine headache pain scores over time after taking either LAT8881 or a placebo, using an 11-point scale where 0 means no pain and 10 means the worst imaginable pain. It also looked at associated symptoms such as nausea, sensitivity to light, and sensitivity to sound, as well as each person's single most bothersome symptom. The reported data shows that for the primary outcome — change in headache pain score — participants in the active (LAT8881) group reported score reductions over time, reaching a change of −4.6 points at the final time point measured, compared with a change of −3.7 points in the placebo group. For the migraine-associated symptoms of nausea, light sensitivity, and sound sensitivity, the reported change in the active group reached −4.3 at the last time point, compared with −2.8 in the placebo group. For each person's most troublesome symptom, the reported changes at the final time point were nearly identical between groups: −3.9 for the active group and −4.0 for the placebo group. Regarding the number of participants who achieved complete freedom from headache pain, the reported data shows that at the final time point, 6 participants in each group reported no headache pain; at earlier time points, only 2 participants in the active group reported this, while none in the placebo group did. The reported data also shows that for the associated symptoms outcome and the most troublesome symptom outcome, scores at some earlier time points were the same between both groups (for example, both showed −1.0 and −1.2 respectively at one mid-point), and individual time-point breakdowns were provided but no formal comparison figures (such as statistical test results) were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04194008 · results posted 2 February 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT04194008) tested a wearable device called Nerivio, worn on the upper arm, in people who experience migraines. A total of 126 people enrolled in an initial observation period, and 99 of those moved on to the treatment phase, with 91 completing it. The trial was measuring things like pain levels, nausea, and sensitivity to light and sound two hours after using the device during a migraine attack, without taking any additional "rescue" pain medication. The reported data shows that, for the primary outcome — pain relief two hours after treatment — 54 out of the participants in the treatment phase reported an improvement (meaning their pain went from severe or moderate down to mild or none, or from mild to none). For the secondary outcomes, the reported data shows that 19 participants reported being completely pain-free at two hours. Among those who had nausea at the start of their migraine, 20 reported it had disappeared at two hours. Of those who had sensitivity to light at the start, 30 reported it had gone; and of those with sensitivity to sound, 29 reported it had gone. The reported data also shows that 52 participants achieved pain relief in at least half of all their treatment sessions, which was recorded as a measure of how consistently the results occurred across multiple uses. The total number of participants used as the denominator for each of these figures was not fully specified in the reported data. It is worth noting that this trial had only one group — everyone used the Nerivio device — so there was no comparison group (such as a placebo or dummy device) included in these reported results. This means the numbers above describe what was measured and recorded, but do not include a direct comparison to an untreated or differently treated group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04161807 · results posted 28 January 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT04161807) involved 42 participants who used a device called Nerivio to treat their migraines. The trial was a single-group study — meaning everyone used the same device, with no comparison group. Thirty-eight of the 42 participants completed the trial, while four did not finish. The main thing the trial was measuring was how many people experienced a meaningful reduction in headache pain two hours after using the device, without taking any additional pain relief medication. Pain reduction was defined as going from severe or moderate pain down to mild or no pain, or from mild pain to no pain. The reported data shows that out of the participants, 19 reported experiencing that level of pain reduction at the two-hour mark. For the secondary measurements — which looked at additional outcomes also at two hours and without extra medication — the reported data shows that 10 participants reported complete disappearance of pain, 10 reported that nausea and/or vomiting disappeared, 9 reported that sensitivity to light disappeared, and 8 reported that sensitivity to sound disappeared. An additional pre-specified measure looked at consistency across multiple treatment uses: the reported data shows that 27 participants achieved pain reduction in at least half of all their individual treatment sessions. It is worth noting that the data as submitted does not include the total number of participants who had each symptom to begin with, so these raw counts should be read carefully rather than treated as percentages of the whole group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02322333 · results posted 9 October 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02322333) enrolled 157 adults in total — 80 in the MLD10 group and 77 in the placebo (dummy treatment) group. Of those, 63 in the MLD10 group and 61 in the placebo group completed the study. The trial was measuring whether MLD10 reduced the number of migraine days and headache days people experienced over a three-month treatment period, compared to a placebo. The reported data shows that for the primary measure — migraine headache days per 28-day period — the MLD10 group averaged 7.12 migraine days at the start (baseline) and 5.53 days by the end of the three-month treatment period. The placebo group averaged 6.92 days at baseline and 4.79 days by the end. For the secondary measures, overall headache days per 28-day period went from an average of 9.01 to 6.89 in the MLD10 group, and from 9.20 to 6.25 in the placebo group. The reported data also shows the total time spent in headache (in minutes per 28-day period), pain severity scores (on a 1–3 scale from mild to severe), and the number of pain medications taken were all measured across each month; in all cases both groups showed changes from their starting values across the three months. For a disability questionnaire called the MIDAS scale (where higher scores mean greater impact on daily life, ranging from 0 to 93), the MLD10 group went from an average score of 33.94 to 27.14, and the placebo group went from 27.03 to 21.40. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03282227 · results posted 19 August 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 342 people who used a patch-based migraine treatment called the M207 Microneedle System (3.8 mg). The patch uses tiny needles to deliver medication through the skin. The trial ran for up to 12 months and was an open-label study, meaning everyone knew what treatment they were receiving and there was no comparison group. Of the 342 people who started, 257 completed at least six months and 127 completed the full study period. The trial was measuring how many people experienced side effects, and also tracking several migraine-related outcomes — such as pain levels and other symptoms — two hours after using the patch. The reported data shows that 323 out of 342 participants experienced at least one treatment-emergent adverse event (that is, any new unwanted health event that occurred after their first patch use) over the course of the study. Reactions at the site where the patch was applied — such as redness, swelling, bruising, pain, and itching — were specifically tracked and counted among these events. For the migraine outcome measures, the data reports the total number of migraine episodes that had usable two-hour data, rather than percentage figures: 2,477 migraine attacks were recorded for the pain freedom measure, 3,315 for the "most bothersome symptom" freedom measure, 4,552 for the pain relief measure, 4,628 for the nausea freedom measure, and 3,410 for the sensitivity-to-light (photophobia) freedom measure. The actual percentage results for each of these outcomes were not reported in the data submitted to ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02593097 · results posted 1 July 2020

According to the results reported on ClinicalTrials.gov, this trial involved 34 people in total — 14 in one group and 20 in the other. It was a "crossover" trial, meaning everyone took both metformin (a medication commonly used for diabetes) and a placebo (a dummy pill with no active ingredient) at different points, with a four-week break in between. The trial was measuring whether metformin had any effect on the number of moderate-to-severe headache days experienced by people with migraines over a 12-week period. By the end of the trial, 24 of the original 34 participants had completed both treatment periods. The reported data shows that over the 12-week treatment periods, people taking metformin recorded an average of 23.64 moderate-to-severe headache days, while people taking the placebo recorded an average of 24.33 days. The reported data also shows that 10.1% of participants taking metformin experienced a reduction of 50% or more in their migraine days — the figure for the placebo group was not reported in the data provided. Regarding unwanted side effects, 3 participants taking metformin and 1 participant taking the placebo were reported to have experienced treatment-related adverse events (that is, unwanted effects that were considered related to what they were taking). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02974153 · results posted 9 June 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02974153) looked at a medicine called ALD403 (tested at two doses — 300 mg and 100 mg) compared to a dummy treatment (placebo) for people with migraines. A total of 1,121 people were enrolled across the three groups, with 1,072 actually receiving a treatment and around 971 completing the study. The trial was primarily measuring how much the number of migraine days per month changed over a 12-week period. The reported data shows that, on average, participants in the 300 mg ALD403 group recorded 8.2 fewer migraine days per month compared to their starting point, those in the 100 mg group recorded 7.7 fewer days, and those in the placebo group recorded 5.6 fewer days. For the secondary measures, the reported data shows that 116 people in the 300 mg group, 95 in the 100 mg group, and 55 in the placebo group had their migraine days cut by at least 75% over 12 weeks. When looking at a 50% reduction over the same period, the numbers were 215, 205, and 144 respectively. The reported data also shows that on the day after receiving their dose, 27.8% of the 300 mg group, 28.6% of the 100 mg group, and 42.3% of the placebo group experienced a migraine. Finally, the average number of days per month that participants used acute migraine medicines (such as triptans) was reported to have fallen by 3.5 days in the 300 mg group, 3.3 days in the 100 mg group, and 1.9 days in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02559895 · results posted 14 May 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 898 people in total across four groups. Participants were randomly assigned to receive one of three doses of a drug called ALD403 (300 mg, 100 mg, or 30 mg) or a placebo (an inactive treatment), given as a single injection. The trial was measuring whether ALD403 reduced the number of days per month that people experienced migraines, tracked over a 12-week period after the injection. The reported data shows that, on average, participants in each group had fewer migraine days per month compared to before the injection. The reduction in the 300 mg group was 4.3 days, the 100 mg group was 3.9 days, the 30 mg group was 4.1 days, and the placebo group was 3.1 days. For the secondary outcomes, the reported data shows that when looking at participants who had their migraine days cut by at least 50% over 12 weeks, 125 people in the 300 mg group, 110 in the 100 mg group, 112 in the 30 mg group, and 83 in the placebo group met that threshold. For a 75% reduction over 12 weeks, the numbers were 66, 49, 55, and 36 respectively. The reported data also shows that the percentage of participants who had a migraine on the day after receiving the injection was 13.9% (300 mg), 14.8% (100 mg), 17.3% (30 mg), and 22.5% (placebo). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02985398 · results posted 21 April 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02985398) enrolled 128 adults who each received a single 300 mg infusion of a drug called ALD403. All 128 participants received the treatment, and 106 completed the study, while 22 did not finish. The trial was primarily measuring safety-related observations — things like unwanted side effects, heart tracing (ECG) readings, blood and lab test results, vital signs (such as blood pressure and pulse), and whether any participants reported thoughts of self-harm. The reported data shows that out of 128 participants, 91 experienced at least one treatment-emergent adverse event — meaning an unwanted health event that occurred on or after the infusion. For heart tracings (ECGs), only a small number of readings across multiple time points were flagged as clinically significant (meaning noteworthy to a doctor): the data shows individual counts of 0 or 1 across twelve separate measurements. Similarly, for laboratory blood and body fluid tests, each of nine separate test categories showed either 0 or 1 participant with a result considered clinically significant. No participants reported thoughts of self-harm at any point, and no clinically significant changes in vital signs were recorded across any of the three measurement time points. As a secondary (additional) outcome, participants were asked at week 104 — roughly two years into the study — to rate how they felt their condition had changed since the start. According to the reported data, out of 96 participants who responded: 47 said they were "very much improved," 33 said "much improved," 11 said "minimally improved," 5 said "no change," and none reported feeling worse in any category. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02275117 · results posted 30 March 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02275117) tested four different doses of a medicine called ALD403 (300 mg, 100 mg, 30 mg, and 10 mg) against a placebo (an inactive treatment) in people with migraines. A total of 665 people were randomised and received treatment across the five groups, and between 92 and 100 people in each group completed the full study. The trial's main goal was to measure how many participants experienced at least a 75% reduction in the number of migraine days over a 12-week period, compared to how many they had before the study began. The reported data shows that for that primary measure — at least a 75% reduction in migraine days — the numbers of participants who reached that level were 38 (out of 120) in the 300 mg group, 37 (out of 123) in the 100 mg group, 33 (out of 122) in the 30 mg group, 33 (out of 130) in the 10 mg group, and 24 (out of 121) in the placebo group. For the secondary measures, the reported data shows that when looking at a 50% reduction in migraine days, the numbers were 65, 65, 65, 54, and 47 participants respectively across the same groups. The reported average reduction in monthly headache days over 12 weeks was approximately 9.6 days for the 300 mg group, 8.9 days for the 100 mg group, 9.2 days for the 30 mg group, 7.5 days for the 10 mg group, and 6.9 days for the placebo group. Very small numbers of participants — between 0 and 4 across all groups, including 1 in the placebo group — were reported to have achieved a complete elimination of all headache days. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01942486 · results posted 26 March 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT01942486) enrolled 35 participants, all of whom received a device or treatment described as an "Investigational Coating." Of the 35 who started the study, 8 completed it, while 27 did not complete it. The trial was measuring the impact of headaches on everyday life, using a standardised questionnaire called the HIT-6 (Headache Impact Test). This questionnaire asks people about how much their headaches affect day-to-day activities and wellbeing, with scores ranging from 36 (least impact) to 78 (most impact). The reported data shows that the average HIT-6 score recorded for the group was 62.3 out of a possible 78. To put that in context, the questionnaire's own guidance notes that scores above 50 suggest headaches are having a substantial effect on daily life. It is important to note that only one outcome measure — this single average score — was reported in the submitted results. No comparison group or "before and after" scores appear to have been reported in the data submitted, so it is not possible to describe any change over time from the figures provided. It is also worth noting that a large proportion of participants — 27 out of 35 — did not complete the trial, and the reasons for this were not detailed in the data provided. Only one primary outcome measure was listed, and no secondary outcome measures were included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01756209 · results posted 25 March 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 160 people in total, split evenly into four groups of 40. All 160 participants completed the trial with no drop-outs. The trial was measuring pain relief over a three-hour period after taking one of four treatments: paracetamol (acetaminophen) alone, ibuprofen alone, magnesium combined with paracetamol, or magnesium combined with ibuprofen. Pain was rated by participants on a scale from 0 (no pain) to 10 (worst possible pain), and the main measurement tracked how pain levels changed from the start up to three hours after taking the treatment. The reported data shows the main result was expressed as a combined score that captures both how much pain relief was felt and how much pain intensity dropped over the three hours — a higher number on this scale indicates greater reported pain relief during that period. The acetaminophen-alone group recorded a score of 5.6, and the ibuprofen-alone group recorded 5.1. The two groups that received magnesium alongside their pain medication recorded lower scores: the magnesium plus paracetamol group scored 2.25, and the magnesium plus ibuprofen group scored 2.2. No other outcome measures were included in the data reported to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02959177 · results posted 21 February 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02959177) tested two doses of a medicine called galcanezumab — 120 mg and 240 mg — against a placebo (a dummy injection with no active ingredient) in people with migraine. A total of 459 participants started the main treatment phase: 115 received the 120 mg dose, 114 received the 240 mg dose, and 230 received the placebo. The main thing the trial was measuring was the average change in the number of days per month on which participants experienced a migraine headache, tracked over six months. The reported data shows that, on average, participants in the 120 mg galcanezumab group had approximately 3.6 fewer migraine days per month compared to their starting level, and the 240 mg group had approximately 3.4 fewer migraine days per month. The placebo group reported an average reduction of about 0.6 days per month. For the secondary measures, the reported data shows that around 50% of participants in the 120 mg group and 48% in the 240 mg group experienced at least a 50% reduction in monthly migraine days, compared with about 20% in the placebo group. Roughly 25% of participants in each active treatment group experienced at least a 75% reduction, versus about 10% in the placebo group, and approximately 9% and 8% respectively had a complete elimination of migraine days in a given month, compared with about 3% in the placebo group. The reported data also shows changes in two further measures: a migraine-specific quality-of-life questionnaire (scored 0–100, where higher means better) improved by an average of about 17 points in the 120 mg group, 16 points in the 240 mg group, and 10 points in the placebo group. Additionally, the number of days per month that participants needed to take acute (rescue) migraine medication fell by an average of about 3.0 days in the 120 mg group, 2.8 days in the 240 mg group, and 0.1 days in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01625988 · results posted 9 January 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT01625988) enrolled 218 people in total — 108 in the LY2951742 group and 110 in the placebo (dummy treatment) group. The trial was measuring whether LY2951742 reduced the number of migraine days and headache days people experienced over a 12-week treatment period, compared to a placebo. Around 94 people in the LY2951742 group and 97 in the placebo group completed the trial. The reported data shows that, for the main outcome — the change in the number of migraine days in the last four weeks of the 12-week period — people in the LY2951742 group reported an average reduction of 4.2 migraine days, compared to an average reduction of 3.0 days in the placebo group. For overall headache days (including non-migraine headaches), the reported reductions were 4.9 days for the LY2951742 group and 3.7 days for the placebo group. For the number of separate migraine attacks, the reported reductions were 3.1 in the LY2951742 group and 2.3 in the placebo group. The reported data also shows that 57.9% to 64.5% of participants in the LY2951742 group (across different time points) had their migraine days cut by more than half, compared to 37.3% to 42.7% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00883051 · results posted 23 December 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 512 people in total across five groups. Each group took a single dose of one of four different strengths of a medicine called lasmiditan (50 mg, 100 mg, 200 mg, or 400 mg) or a dummy pill (placebo) during a migraine attack. The main thing the trial was measuring was whether participants' headache pain dropped from moderate or severe down to mild or none within two hours of taking their dose. Not everyone who enrolled actually used their medication during the study — the numbers who took at least one dose were 82, 82, 71, 70, and 86 across the five groups respectively. The reported data shows that for the main measure — headache pain dropping to mild or none at two hours — the placebo (dummy pill) group had the highest reported response at 74.1%, compared with 57.0% for the 50 mg group, 35.8% for the 100 mg group, 49.3% for the 200 mg group, and 35.3% for the 400 mg group. For the secondary measures, the percentage of participants who reported being completely headache-free at two hours was 13.9% (50 mg), 13.6% (100 mg), 18.8% (200 mg), 27.9% (400 mg), and 7.4% (placebo). Among those who did become pain-free at two hours, the reported data shows that headache came back within 24 hours for roughly half to nearly two-thirds of participants across all groups (ranging from 50.0% to 62.9%), with the placebo group at 57.1%. The reported data also shows that two hours after taking the dose, nausea was reported by 31.65% (50 mg), 25.00% (100 mg), 35.29% (200 mg), 26.87% (400 mg), and 40.74% (placebo) of participants, and sensitivity to sound (phonophobia) was reported by 41.77%, 23.75%, 39.71%, 31.34%, and 48.15% respectively. Some figures for headache severity categories were not fully reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02794441 · results posted 3 December 2019

According to the results reported on ClinicalTrials.gov, this trial compared dexamethasone (a steroid medication) with a placebo (an inactive treatment) in people attending an emergency department (ED) with headache. A total of 12 people started the trial — 7 received dexamethasone and 5 received placebo. Six people in the dexamethasone group and all 5 in the placebo group completed the study. The trial was measuring whether headache came back within 48 hours of leaving the ED, as well as several other things including pain levels at discharge, patient satisfaction, headache return over 7 days, and whether anyone came back to the ED within 7 days. The reported data shows that for the main outcome — headache returning within 48 hours — 1 out of 7 participants in the dexamethasone group and 1 out of 5 in the placebo group reported a recurrence. For the outcome of being completely pain-free and staying that way through to 48 hours without needing extra medication, 1 participant in each group met this measure. At the 7-day follow-up, no participants in either group reported headache recurrence. Regarding return visits to the ED within 7 days, 1 person in the dexamethasone group and 0 in the placebo group returned. The reported data also includes pain intensity scores and patient satisfaction ratings at discharge, though the breakdown of individual score categories was not clearly labelled in the submitted data, so a full plain-English description of those specific numbers cannot be provided without risk of misrepresentation. It is worth noting that this was a very small trial — only 12 people in total — and the results as submitted reflect that limited scale. The reported data shows numbers across the two groups, but no broader conclusions about the treatment can be drawn from a trial of this size alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00384774 · results posted 2 December 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 130 people in total across seven groups. Forty-two participants received a placebo (a dummy treatment with no active ingredient), and the remaining 88 received one of six different doses of lasmiditan — ranging from 2.5 mg up to 45 mg — given by intravenous infusion (a drip into a vein). All 130 participants completed the study. The trial was measuring how people's migraine headache severity changed in the hours after receiving the infusion, as well as tracking other symptoms like nausea, vomiting, sensitivity to light, and sensitivity to sound. The reported data shows that for the main outcome — the number of people whose headache went from moderate or severe down to mild or no pain within two hours — the numbers varied across groups. In the placebo group, 23 out of 42 participants met this measure. Across the lasmiditan dose groups: 2 out of 4 (2.5 mg), 10 out of 12 (5 mg), 11 out of 24 (10 mg), 10 out of 28 (20 mg), 5 out of 16 (30 mg), and 1 out of 4 (45 mg) met this measure. For the secondary outcomes, the reported data shows that the percentage of participants completely free of headache pain at two hours was low across all groups, ranging from 0% in several groups up to 25% in the 45 mg group (which had only 4 participants) and 3.6% in the 20 mg group. For sustained headache response — meaning the improvement lasted without returning for 24 hours — the numbers of participants who did *not* achieve this (i.e., had a recurrence or needed rescue medication) were also reported across all groups. The reported data also shows that the number of participants free from all associated symptoms (nausea, vomiting, light sensitivity, and sound sensitivity) at two hours was small in every group: for example, 7 out of 42 in the placebo group and between 0 and 6 participants across the various lasmiditan dose groups. It is worth noting that some dose groups contained very few participants (as few as 4), which means the percentages for those groups are based on a very small number of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03763058 · results posted 18 July 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT03763058) enrolled 20 adults who experience migraines, all of whom received a music-based intervention over three months. Eighteen participants completed the study, and two did not finish. The trial was measuring whether listening to music regularly could change how often migraines occurred, how long they lasted, how severe they were, and how much they affected daily life — including mood. The reported data shows that, on average, participants had about 8.45 migraine days per month before the intervention, and about 5.65 migraine days per month by the third month. For duration, the average length of a migraine attack was reported as around 10.95 hours before the intervention and around 5.5 hours at the three-month mark. The number of severe migraine episodes was reported as an average of 2.9 before and 1.7 after. The trial also used a standard questionnaire called the HIT-6 to measure how much migraines disrupted daily life, where a higher number means a bigger impact — the reported scores were 62.75 before and 59.1 after (on a scale of 36 to 78). Anxiety and depression were measured separately using another questionnaire (scored 0–21 each, where higher means worse); anxiety scores were reported as 9.05 before and 7.4 after, and depression scores as 6.45 before and 4.0 after. No other comparison groups were included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02991430 · results posted 19 June 2019

According to the results reported on ClinicalTrials.gov, this trial involved 45 people in total across three groups: one group received a placebo (an inactive treatment) taken twice daily (14 people), one group received an active treatment twice daily (15 people), and one group received an active treatment once daily (16 people). The trial was looking at migraine headache days — that is, how many days per month participants experienced migraines — and tracked this over a treatment period and a follow-up observation period. The study also measured things like pain medication use, how severe headache pain felt, quality of life, and mood (specifically depression scores). The reported data shows that, unfortunately, no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — not for the primary measure (change in migraine headache days) nor for any of the six secondary measures, including medication use, pain scores, quality of life, and depression. This means the actual numbers comparing what happened before and after treatment across the three groups were not reported in the structured results data available on ClinicalTrials.gov. It is also worth noting that a notable number of participants did not complete the trial — for example, by the end of the second treatment period, roughly half of those who started had not finished. Because no outcome numbers were submitted, it is not possible to describe what the trial found in terms of measured results. The data was simply not reported in the registry entry. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02933060 · results posted 3 June 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people in total — 25 in a group that received an intravenous (IV) fluid bolus (a larger, faster drip of fluids through a drip in the arm) and 25 in a control group. One person in the control group did not complete the study. The trial was measuring whether receiving an IV fluid bolus made a difference to headache pain, using a pain scale of 0 (no pain) to 10 (worst possible pain), as well as several other related measurements at one and two hours after the treatment began. The reported data shows that at 60 minutes — the main outcome the trial was designed to measure — the IV fluid bolus group reported an average pain score of 4.5 out of 10, while the control group reported 4.9 out of 10. The researchers had noted beforehand that a difference of at least 1.3 points on this scale would be considered meaningful; the difference seen here was 0.4 points. At 120 minutes, the reported average pain scores were 5.9 for the IV fluid bolus group and 5.5 for the control group. The reported data also shows that 38% of the IV fluid bolus group and 32% of the control group were free of pain at two hours. For the other secondary outcomes, the reported data shows that 72% of the IV fluid bolus group and 75% of the control group had no or only mild difficulty carrying out daily activities due to their headache at 60 minutes. When asked whether they would want the same IV fluid treatment on a future visit, 79% of the IV fluid bolus group and 67% of the control group said yes. Additionally, 21% of the IV fluid bolus group needed extra pain medications compared with 32% of the control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01785459 · results posted 3 April 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 23 people in total — 11 in a "Standard Care" group and 12 in a "Treatment" group. All 23 participants completed the study with no drop-outs. The trial was measuring how long people stayed in the emergency department, whether any complications occurred during or after their visit, and how their headache symptoms changed after treatment. The reported data shows that the average time spent in the emergency department was 158 minutes for the Standard Care group and 131 minutes for the Treatment group. Regarding complications — which included things like ongoing local pain, bleeding, infection, or a serious reaction to an injection — 1 participant in the Standard Care group and 2 participants in the Treatment group experienced at least one such complication within 72 hours. For headache symptom relief, the reported data shows that 7 participants in the Standard Care group and 9 in the Treatment group reported headache relief; 3 in the Standard Care group and 2 in the Treatment group reported partial relief; 1 in the Standard Care group and 0 in the Treatment group reported no relief; and 0 in the Standard Care group and 1 in the Treatment group reported their headache worsened. The data on treatment failure rates and repeat emergency visits within 72 hours was not reported separately in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02630459 · results posted 13 March 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02630459) involved people who experience migraines. In the main double-blind phase — where neither participants nor researchers knew who was receiving which treatment — 475 people were assigned to receive either a placebo (a dummy injection with no active ingredient) or one of three doses of a medicine called erenumab (28 mg, 70 mg, or 140 mg), given once a month. A further open-label phase (where everyone knew what was being given) involved around 459 additional participants. A smaller optional sub-study looked at two different injection-device formats. The trial's main goal was to measure how the number of migraine days per month changed over months four, five, and six of the double-blind phase compared to the starting point. The reported data shows that, on average, the number of monthly migraine days changed as follows from the starting point: the placebo group saw an increase of 0.06 days; the 28 mg erenumab group saw a reduction of 1.19 days; the 70 mg group saw a reduction of 2.25 days; and the 140 mg group saw a reduction of 1.83 days. For a secondary measure — the proportion of people whose monthly migraine days fell by at least half — the reported figures were 7.4% in the placebo group, 19.7% in the 28 mg group, 28.9% in the 70 mg group, and 27.2% in the 140 mg group. The reported data also shows changes in the number of days per month that participants used specific migraine rescue medicines (triptans or ergotamines): the placebo group averaged an increase of 0.88 days, while the erenumab groups averaged reductions of 0.19 days (28 mg), 1.19 days (70 mg), and 1.16 days (140 mg). In the injection-device sub-study, 100% of participants in both device groups reported successfully administering a full dose at both measured time points. Regarding recorded adverse events (unexpected medical occurrences during the trial), the reported data shows that in the double-blind phase, 92 of 136 placebo participants, 40 of 66 in the 28 mg group, 95 of 135 in the 70 mg group, and 95 of 137 in the 140 mg group experienced at least one such event. Serious adverse events were recorded in 4, 1, 3, and 0 participants in those respective groups, and no fatal adverse events were reported in the double-blind phase. During the open-label phase, no fatal adverse events were reported either. These numbers describe what was recorded and counted — they do not on their own indicate whether any event was caused by the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02867709 · results posted 29 January 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02867709) enrolled 1,686 people across three groups: one group received a placebo (a dummy treatment with no active ingredient), one received a 25 mg dose of ubrogepant, and one received a 50 mg dose of ubrogepant. Ubrogepant is a medicine being investigated for migraine attacks. The trial was primarily measuring two things two hours after taking the study medication: how many participants went from moderate or severe head pain to no pain at all ("pain freedom"), and how many participants no longer had the single migraine symptom they had found most bothersome at the start — which could be sensitivity to light, sensitivity to sound, or nausea. The reported data shows that for the first primary measure — pain freedom at two hours — 14.3% of participants in the placebo group, 20.7% in the 25 mg ubrogepant group, and 21.8% in the 50 mg ubrogepant group reported no pain. For the second primary measure — absence of their most bothersome migraine symptom at two hours — the reported figures were 27.4% for placebo, 34.1% for the 25 mg group, and 38.9% for the 50 mg group. The reported data also shows results for several secondary measures. For general pain relief (headache reducing from moderate/severe to mild or none) at two hours, the figures were 48.2% (placebo), 60.5% (25 mg), and 62.7% (50 mg). For sustained pain relief lasting from two to 24 hours, the reported percentages were 21.0%, 32.5%, and 36.7% respectively. Sustained pain freedom over the same period was reported as 8.2%, 12.7%, and 14.4%. Finally, for absence of light sensitivity at two hours, the figures were 35.5%, 39.3%, and 43.8% across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01604785 · results posted 31 December 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 74 people in total — 37 in an experimental treatment group and 37 in a standard treatment group — who were treated in an Emergency Department setting. The trial was measuring changes in self-reported pain levels, whether headaches returned within 24 hours of leaving the Emergency Department, and how long participants stayed in the Emergency Department after receiving their medication. Not everyone who started the trial completed it: 7 people in the experimental group and 1 person in the standard group did not complete the study. The reported data shows that, for the main measurement (pain levels rated on a 0–10 scale), participants in the experimental group reported an average pain reduction of 51%, while those in the standard treatment group reported an average reduction of 59%. For the first secondary measurement, when participants were contacted by phone 24 hours after leaving the Emergency Department, 25% of the experimental group reported their headache had returned and was worse than when they were discharged, compared with 66.7% in the standard treatment group. For the second secondary measurement, the reported data shows that the experimental group spent an average of 79 minutes in the Emergency Department from the time they received their medication until discharge, compared with 111 minutes for the standard treatment group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02792517 · results posted 20 December 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 41 participants, all of whom were taking a combined oestrogen/progestin oral contraceptive pill and were assigned to also receive a single dose of erenumab 140 mg (a migraine prevention medicine). Of the 41 who started, 24 received erenumab and 21 completed the study. The trial was not measuring whether the medicines treated any condition — instead, it was measuring how the body absorbs and processes the hormones in the contraceptive pill (specifically the hormones ethinyl estradiol and two active components of the progestin, norgestrel and norelgestromin) with and without erenumab present. This type of measurement is called a pharmacokinetic (drug-level) study, meaning it tracks how much of a substance gets into the bloodstream and how long it stays there. The reported data shows that hormone blood levels were measured at the end of a contraceptive cycle without erenumab (cycle 2) and then again at the end of a cycle taken 11 days after the erenumab injection (cycle 3). For ethinyl estradiol, the reported peak blood level (highest concentration reached) was 132 pg/mL without erenumab and 143 pg/mL with erenumab; the reported total exposure over 24 hours was 1,010 pg/mL·hr without erenumab and 1,060 pg/mL·hr with erenumab. For norgestrel, the reported peak level was 2,690 pg/mL without erenumab and 2,860 pg/mL with erenumab; total 24-hour exposure was 50,700 pg/mL·hr and 52,400 pg/mL·hr respectively. For norelgestromin, the reported peak level was 1,800 pg/mL without erenumab and 1,870 pg/mL with erenumab; total 24-hour exposure was 16,800 pg/mL·hr and 16,900 pg/mL·hr respectively. No further outcome data beyond these hormone level measurements was reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02621931 · results posted 6 December 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02621931) enrolled 1,130 adults across three groups: one group received a placebo (an inactive injection) throughout the study, one group received a single higher dose of fremanezumab (675 mg) followed by placebo injections, and one group received the same starting dose followed by lower monthly doses (225 mg). The trial was measuring changes in the number of moderate-to-severe headache days per month, migraine days per month, use of acute headache medicines, and how many participants experienced unwanted medical events (adverse events) over a 12-week period. The reported data shows that, on average, participants in the placebo group had about 2.5 fewer moderate-to-severe headache days per month compared to before the trial started. In the single-dose fremanezumab group, the reported reduction was about 4.2 days per month, and in the monthly-dosing fremanezumab group it was about 4.5 days per month. For migraine days specifically, the placebo group reported a reduction of about 3.2 days per month, compared to approximately 4.9 and 5.0 days per month in the two fremanezumab groups respectively. When looking at whether participants achieved at least a 50% reduction in their moderate-to-severe headache days over the full 12 weeks, the reported figures were around 21.6% of placebo participants, 41.3% in the single-dose group, and 40.0% in the monthly-dosing group. Regarding use of acute headache medicines, the placebo group used them on about 2.0 fewer days per month, while the fremanezumab groups reported reductions of about 3.6 and 4.2 fewer days per month. The reported data also shows that unwanted medical events (adverse events) during the trial were recorded for 240 out of 375 placebo participants, 265 out of 376 in the single-dose fremanezumab group, and 270 out of 379 in the monthly-dosing group. Serious adverse events — meaning those that were life-threatening, required hospitalisation, or caused significant disability — were reported for 6 placebo participants, 3 in the single-dose group, and 5 in the monthly-dosing group. The trial reported these numbers but did not draw conclusions about the cause of these events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02848326 · results posted 6 December 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02848326) looked at a medicine called atogepant, which was being tested as a daily tablet to reduce migraines. A total of 834 people started the 12-week treatment period across six groups: one group received a placebo (a dummy tablet with no active ingredient), and five groups received different doses of atogepant — either once a day (QD) or twice a day (BID). The main thing the trial was measuring was how much the average number of migraine days per month changed from the start of the trial to the end of the 12-week treatment period. The reported data shows that, on average, people in the placebo group had about 2.85 fewer migraine days per month by the end of the treatment period compared to where they started. For the atogepant groups, the reported reductions ranged from approximately 3.55 to 4.23 fewer migraine days per month, depending on the dose. For the secondary outcomes, the reported data shows similar patterns for headache days per month, with the placebo group averaging a reduction of about 2.93 days and the atogepant groups ranging from roughly 3.86 to 4.32 fewer days. When it came to days per month when people used other medicines to treat a migraine attack, the placebo group reported a reduction of about 2.42 days, while atogepant groups reported reductions ranging from roughly 3.53 to 3.86 days. The reported data also shows that between about 40% of people in the placebo group and up to around 62% in one atogepant group had their monthly migraine days cut by at least half over the 12-week period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02614183 · results posted 29 November 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 862 people across three groups: 434 received a placebo (a dummy injection with no active ingredient), 214 received a monthly injection of galcanezumab at 120 mg, and 214 received it at 240 mg. The trial ran for six months of treatment followed by a follow-up period. It was measuring whether galcanezumab reduced the number of days per month that participants experienced migraine headaches, compared to the placebo group. The reported data shows that, on average over the six months, the placebo group reported a reduction of about 2.8 migraine days per month from their starting point, while the 120 mg group reported a reduction of about 4.7 days and the 240 mg group about 4.6 days. For secondary measurements, the reported data shows that around 62% of the 120 mg group and 61% of the 240 mg group, on average, had their monthly migraine days cut by at least half — compared to about 39% in the placebo group. Complete freedom from migraines in a given month was reported in around 16% of the 120 mg group and 15% of the 240 mg group, versus about 6% in the placebo group. The trial also measured the number of hours spent with a headache per month; the placebo group reported a reduction of roughly 15.7 hours, while both galcanezumab groups reported reductions of around 29–30 hours. Separate questionnaires measuring how migraines affected daily life and participants' own rating of their illness severity also showed differences between groups, with the reported numbers favouring the galcanezumab groups over placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00610727 · results posted 5 November 2018

According to the results reported on ClinicalTrials.gov, this trial involved 54 people in total across six groups. One group of 14 participants took part in a comparison and crossover phase (receiving both an inhaled form of a medicine called prochlorperazine and an intravenous, or needle-into-vein, version), while the remaining five groups of 8 people each received either different doses of inhaled prochlorperazine (1.25 mg, 2.5 mg, 5 mg, or 10 mg) or an inhaled placebo (a dummy treatment with no active ingredient). The trial was measuring how the drug moved through the body when breathed in — specifically how quickly it reached its peak level in the bloodstream, how much of the dose actually got absorbed, and whether higher doses led to predictably higher levels in the body. The reported data shows that the time it took for the drug to reach its highest level in the blood (called "time to peak") was very short across all groups — ranging from roughly 0.025 to 0.042 hours (that is, about 1.5 to 2.5 minutes) for both the inhaled and intravenous doses. For the secondary outcomes, the reported data shows that the fraction of the inhaled dose that was absorbed into the body was reported as 0.98, meaning close to the full dose appeared to reach the bloodstream. The trial also looked at whether doubling the dose led to a proportional doubling of drug levels in the body; the reported figure for this relationship (called a "slope") was 1.089, which the study's own description notes is close to a value of 1.000 — described as "perfect" proportionality — and within a range the researchers described as indicating a consistent delivery system. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02342743 · results posted 19 September 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 73 participants in a single active treatment group. Of those, 58 completed the initial baseline recording period and moved into the treatment phase, and 47 finished the full treatment period. The trial was measuring changes in headache patterns — specifically how often participants had headache days and how much pain relief medication they used — comparing a 28-day window at the start of the study (baseline) to a 28-day window at the end of 12 weeks of treatment. The reported data shows that, on average, participants had 3.12 fewer headache days per 28-day period by the end of treatment compared to their baseline. Their use of acute (short-term pain relief) medication fell by an average of 8.11 doses per 28 days. These were the two main things the trial set out to measure. The reported data also shows a number of secondary (additional) measurements. On average, participants recorded 3.35 fewer migraine days per 28-day period, 3.10 fewer moderate-to-severe headache days, and 3.12 fewer individual headache episodes per 28 days. The total number of hours spent experiencing headaches each month fell by an average of 27.22 hours. These are descriptive numbers only — there was no comparison group reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01184508 · results posted 12 September 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 45 people in the placebo group and 42 people in the LY2300559 (investigational drug) group, with 29 and 27 participants respectively completing the full study. The trial was measuring whether LY2300559 had any effect on migraines compared to a placebo (a dummy treatment with no active ingredient). Researchers tracked several things over 12 weeks, including how often migraines occurred, how long they lasted, how severe they were, and how both doctors and patients rated any change in symptoms. The reported data shows that, for the main outcome — the number of migraine attacks per month — the placebo group started at an average of 5.2 attacks and came down to 3.4 by the end of the 12 weeks, while the LY2300559 group started at 5.5 attacks and came down to 2.8. For migraine days per month, the placebo group went from 8.8 days down to 6.3, and the LY2300559 group went from 10.5 days down to 4.9. For average migraine duration, both groups showed figures in a similar range across the study period (roughly 12 to 18 hours), with no large differences reported between them. On the severity scale, the reported data shows a spread across "mild," "moderate," and "severe" categories at both time points for each group, though the breakdown figures are not straightforward to summarise without more context. On the clinician and patient impression scales (where 1 means "very much improved" and 4 means "no change"), both groups started at 4.0, and by the end the placebo group reached 3.0 (clinician) and 2.5 (patient), while the LY2300559 group reached 2.0 on both scales. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02605174 · results posted 30 July 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called lasmiditan, tested at three different doses (50 mg, 100 mg, and 200 mg), compared against a dummy pill (placebo) in people experiencing migraine. In total, 3,005 people were enrolled across all groups. The trial had two main things it was measuring: how many people were completely free of headache pain two hours after taking the study drug, and how many people no longer had their most bothersome migraine symptom — such as nausea, sensitivity to light, or sensitivity to sound — at that same two-hour mark. The reported data shows that for the main measure of being completely headache-pain-free at two hours, the figures were 28.6% for the 50 mg group, 31.4% for the 100 mg group, and 38.8% for the 200 mg group, compared with 21.3% for the placebo group. For the second main measure — no longer having the most bothersome symptom at two hours — the reported figures were 40.8% (50 mg), 44.2% (100 mg), and 48.7% (200 mg), compared with 33.5% for placebo. The reported data also shows that for the broader measure of headache "relief" (meaning pain reduced to mild or gone), the figures were 59.0%, 64.8%, and 65.0% for the three lasmiditan doses respectively, versus 47.7% for placebo. The percentage of people who needed to take a rescue medication was reported as 31.9% (50 mg), 26.4% (100 mg), and 18.9% (200 mg), compared with 40.8% for placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01071317 · results posted 26 July 2018

According to the results reported on ClinicalTrials.gov, this trial involved 50 people in total — 25 in a "Comprehensive Care" group and 25 in a "Typical Care" group. Of these, 23 people in each group completed the trial (2 in each group did not finish). The trial was measuring how much migraines affected participants' daily lives, as well as their satisfaction with their treatment, how comfortable they felt managing their condition, and whether they returned to the emergency department for headache care. The reported data shows that, for the main measure — a standard questionnaire called the Headache Impact Test 6 (HIT-6) — the Comprehensive Care group scored an average of 59 out of 78, while the Typical Care group scored an average of 56 out of 78. On this scale, a lower score means less impact on daily life, and a higher score means more impact; the full range runs from 36 (least impact) to 78 (most impact). For the secondary measures, the reported data shows that 4 participants in each group said they were unsatisfied with their treatment. When asked how comfortable they felt managing their condition, 10 participants in the Comprehensive Care group and 6 in the Typical Care group reported feeling "very comfortable." Regarding emergency department visits for headache, 1 participant in the Comprehensive Care group and 3 in the Typical Care group were reported to have returned to the emergency department. It is worth noting that the data as submitted does not include information about when these scores were measured (for example, before or after treatment), so the numbers above reflect the values as reported without further context about timing or change over time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01952574 · results posted 10 July 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01952574) looked at a medicine called erenumab for people with migraines. In the main double-blind phase — where neither participants nor researchers knew who was getting which treatment — 483 people took part across four groups: one group received a dummy (placebo) injection once a month, and three groups received different doses of erenumab (7 mg, 21 mg, or 70 mg) once a month. A further 383 people then continued into an open-label phase where everyone received erenumab and knew what they were taking. A smaller substudy of 83 people looked at whether participants could successfully inject themselves at home using either a prefilled syringe or an autoinjector pen. The reported data shows that the main thing being measured in the double-blind phase was how much the number of migraine days per month changed over 12 weeks compared to before the trial started. According to the results reported on ClinicalTrials.gov, the placebo group recorded a change of −2.28 migraine days per month, meaning they had about 2.28 fewer migraine days on average. The reported figures for the erenumab groups were: −2.18 days for the 7 mg group, −2.39 days for the 21 mg group, and −3.40 days for the 70 mg group. A secondary measure looked at the proportion of participants whose migraine days fell by at least half: the reported figures were 29.9% for the placebo group, 28.8% for the 7 mg group, 34.4% for the 21 mg group, and 46.5% for the 70 mg group. The number of migraine attacks per month also decreased across all groups, with reported changes of −1.44 (placebo), −1.07 (7 mg), −1.42 (21 mg), and −1.84 (70 mg). For the home-use substudy, the reported data shows that the vast majority of participants in both the prefilled syringe group and the autoinjector pen group were recorded as successfully self-administering a full dose at their scheduled injection days, though the detailed breakdown across each dosing visit was not fully distinguishable from the data as submitted. The reported data also shows that unintended medical events (called adverse events) were tracked throughout the trial. In the double-blind phase, adverse events of any kind were reported in 81 of 160 placebo participants, 57 of 108 in the 7 mg group, 55 of 108 in the 21 mg group, and 57 of 107 in the 70 mg group. Serious adverse events — defined as those that were life-threatening, required hospitalisation, or caused significant disability — were reported in small numbers across all groups. This summary only describes what was counted and recorded; it does not indicate anything about whether these events were caused by the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02066415 · results posted 21 June 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 667 people in total — 286 in the placebo group, 191 in the erenumab 70 mg group, and 190 in the erenumab 140 mg group. The trial was measuring how erenumab (given as a monthly injection) compared to a placebo (an inactive injection) in people with migraines, over a 12-week treatment period. The main thing being tracked was how the number of migraine days per month changed from the start of the trial to the end of treatment. The reported data shows that, on average, the placebo group experienced about 4.2 fewer migraine days per month by the end of the trial, while both the 70 mg and 140 mg erenumab groups each reported around 6.6 fewer migraine days per month. Looking at one of the secondary measures, the reported data shows that roughly 23.5% of placebo participants had their monthly migraine days cut by at least half, compared to about 39.9% in the 70 mg group and 41.2% in the 140 mg group. The number of days per month participants used specific migraine pain-relief medicines also changed — the placebo group reported a reduction of about 1.6 days, compared to around 3.5 days for the 70 mg group and 4.1 days for the 140 mg group. Reported total hours of headache per month also decreased across all three groups, with reductions of approximately 55 hours (placebo), 65 hours (70 mg), and 75 hours (140 mg). The reported data also recorded how many participants experienced unwanted side effects during the trial. In the placebo group, 110 participants reported some kind of side effect, compared to 83 in the 70 mg group and 88 in the 140 mg group. Separately, the trial tested whether participants developed antibodies (proteins the body can produce in response to a medicine) to erenumab — 11 participants in the 70 mg group and 3 in the 140 mg group were reported to have developed these, though none were found to be the neutralising type (meaning none were confirmed to block the medicine's activity). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01667250 · results posted 20 June 2018

According to the results reported on ClinicalTrials.gov, this trial involved 73 people who first went through a four-week observation period with no treatment, to establish a baseline. After that, 59 of those participants moved into a randomised phase — meaning they were assigned by chance to one of two groups: 30 people used an active version of a device called GammaCore (a non-invasive nerve-stimulating device applied to the neck), and 29 people used a sham (dummy) version that looked the same but was not active. The trial was measuring safety, headache frequency, headache severity, pain relief medication use, and quality of life. The reported data shows that, for the primary outcome of safety, 6 participants in the active device group and 5 in the sham group experienced adverse events (unwanted or unexpected occurrences recorded during the trial). For the secondary outcomes, the average number of headache days changed by minus 1.5 days in the active device group and minus 0.2 days in the sham group, comparing the run-in period to the randomised period. Regarding pain relief medication use, the reported data shows 26 participants in the active group and 25 in the sham group used some form of abortive (headache-stopping) medication during the randomised period. For quality of life, scores on the SF-12 physical health scale were reported at around 40–45 for the active group and 36–38 for the sham group across time points, while mental health scores were reported in the mid-to-upper 40s for both groups. The full breakdown of headache severity day counts across mild, moderate, and severe categories was also reported but was not provided in a format that allows straightforward plain-language comparison across all sub-categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01825941 · results posted 8 June 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01825941) involved 208 people who came to an emergency department with headache. Participants were randomly given one of two treatments: metoclopramide combined with diphenhydramine (an antihistamine), or metoclopramide combined with a placebo (a dummy treatment with no active ingredient). The trial was measuring how many people achieved "sustained headache relief" — defined as their headache dropping to a "mild" or "none" level within two hours, and staying at that level for the following 48 hours. Pain levels were checked every 30 minutes while participants were in the emergency department, and then again by phone 48 hours later. The reported data shows that out of 104 people who started in the metoclopramide plus diphenhydramine group, 100 completed the study, and 40 of those participants met the definition of sustained headache relief. In the metoclopramide plus placebo group, 103 of the 104 who started completed the study, and 38 participants met the same definition. No other outcome measures were included in the data submitted to ClinicalTrials.gov, so further details about side effects or other results were not reported there. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02191579 · results posted 7 June 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 282 participants in total — 140 in the BOTOX® group and 142 in the Topiramate/BOTOX® group. The trial was measuring whether BOTOX® injections alone, or a combination of the oral medication topiramate followed by BOTOX®, had any effect on the number of headache days experienced by people with frequent migraines. Participants kept a daily electronic diary over the course of the study, and the main thing being measured was how many people had at least half as many headache days by around week 32 compared to when they started. The reported data shows that for the primary measure — the proportion of people whose headache days dropped by 50% or more from their starting point — 40% of participants in the BOTOX®-only group reached that threshold, compared with 12% in the topiramate group. For the secondary measures, the reported average change in headache days per 28-day period was a reduction of 8.3 days in the BOTOX® group and 2.1 days in the topiramate group (where a lower number means fewer headache days). A separate questionnaire called the HIT-6, which scores how much headaches affect daily life on a scale from 36 to 78, showed an average score change of −5.6 in the BOTOX® group and −1.3 in the topiramate group (where a lower score indicates less impact). The reported data also shows that 27.1% of the BOTOX® group had a 70% or greater reduction in headache days, compared with 8.5% in the topiramate group. It is worth noting that more participants in the topiramate/BOTOX® group did not complete the study compared to the BOTOX®-only group, which may be relevant context when reading these numbers. The reasons for non-completion were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03217968 · results posted 7 June 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT03217968) enrolled 59 adult participants, all of whom received the active treatment — a form of external nerve stimulation applied to the forehead area (called e-TNS). The trial was measuring how participants' migraine headache pain and associated symptoms responded in the hours after using the device. Of the 59 who started, 48 completed the study and 11 did not finish. The reported data shows that, out of the participants assessed, 17 reported being completely free of headache pain two hours after starting the e-TNS session. For the most bothersome symptom linked to their migraine (such as nausea, light sensitivity, or sound sensitivity), 29 participants reported that symptom was gone at the two-hour mark. Looking at the secondary measures, 34 participants reported their headache had reduced from moderate or severe down to mild or no pain at two hours. Freedom from migraine-associated symptoms including light sensitivity, sound sensitivity, nausea and vomiting at two hours was reported for 22 participants. Between two and 24 hours after the session, 24 participants reported taking additional migraine medication. Sustained pain freedom — meaning no headache, no additional medication needed, and no return of pain within 24 hours — was reported for 12 participants. The data does not include percentage figures calculated from these numbers, as only raw participant counts were reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01086358 · results posted 1 May 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 59 people in total — 30 in one group and 29 in the other. It used a "crossover" design, meaning participants tried both treatments one after the other: their usual prescribed triptan (a common type of migraine medicine) and a combination tablet called Treximet (which contains sumatriptan and naproxen sodium). The trial was measuring how much productive time — both at work and during everyday activities — people lost when treating a migraine attack, using a tool called the Workplace Productivity and Activity Impairment Scale (WPAI). Of the 59 who started, 37 completed both phases and were included in the main analysis. The reported data shows that, for the main outcome of total hours of productivity lost per migraine attack, the usual triptan group reported an average of 4.15 hours lost, while the Treximet group reported an average of 2.44 hours lost. Breaking this down further, the reported data shows lost work hours averaged 2.25 (usual triptan) versus 1.23 (Treximet), and lost everyday activity hours averaged 1.89 (usual triptan) versus 1.22 (Treximet). For a separate measure called the Migraine-ACT — a short four-question scale where a score of 3 or more out of 4 is considered a "favourable" response to treatment — the reported data shows 46% of participants scored favourably when using their usual triptan, compared with 71% when using Treximet. It is worth noting that the numbers above come from a relatively small group of 37 people who completed the full study, and the data was not reported in a way that allows broader conclusions to be drawn. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00825500 · results posted 24 April 2017

According to the results reported on ClinicalTrials.gov, this trial involved 366 people split across three groups: 125 received an inhaled placebo (a dummy treatment with no active ingredient), 121 received a low dose (1.25 mg) of inhaled loxapine, and 120 received a higher dose (2.5 mg) of inhaled loxapine. All participants who started the trial completed it. The trial was measuring whether inhaled loxapine reduced migraine pain and associated sensitivity to light (photophobia) two hours after treatment. For the main measure — pain relief at two hours — the reported data shows that 56 out of 125 participants in the placebo group, 65 out of 121 in the low-dose loxapine group, and 66 out of 120 in the higher-dose loxapine group went from moderate or severe pain before treatment down to mild or no pain at the two-hour mark. For the secondary measure — being free of light sensitivity at two hours — the reported data shows 59 out of 125 placebo participants, 47 out of 121 low-dose loxapine participants, and 54 out of 120 higher-dose loxapine participants were free of photophobia at that time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01667679 · results posted 14 March 2017

According to the results reported on ClinicalTrials.gov, this trial involved 275 adults in total (138 in one group and 137 in another). It was a "crossover" trial, meaning participants tried both treatments at different times: a 20 mg sumatriptan nasal powder and a 100 mg sumatriptan tablet (each taken alongside a dummy/placebo version of the other). The trial ran across two treatment periods, each lasting up to 12 weeks. The main thing being measured was how much migraine pain changed in the 30 minutes after taking the treatment, using a scoring system called SPID-30, where a higher score means a greater reported drop in pain. The reported data shows that for the main measure (SPID-30 over 30 minutes), the nasal powder group scored 10.80 on average, while the tablet group scored 7.41 — with higher numbers indicating a greater reported reduction in pain intensity on the scale used. For secondary measures, the reported data shows that at 30 minutes after dosing, approximately 49% of migraine attacks treated with the nasal powder and 35% treated with the tablet were recorded as having at least some pain reduction; and about 18% of attacks in the nasal powder group and 11% in the tablet group were recorded as reaching complete pain freedom at that 30-minute mark. By 120 minutes, those pain-freedom figures rose to around 53% for the nasal powder and 45% for the tablet. The reported median time to complete pain freedom was 91 minutes for the nasal powder and 121 minutes for the tablet. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01516892 · results posted 6 January 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01516892) involved 716 people who all received BOTOX® (botulinum toxin type A). The trial was looking at people with chronic migraine and tracked them over a long period — up to about two years (108 weeks). It measured things like how many days per month participants experienced headaches, and how much headaches were affecting their day-to-day life. Of the 716 people who started, 373 completed the trial and 343 did not finish. The reported data shows that, on average, participants started with around 22 headache days in a 28-day period at the beginning of the trial (the "baseline"). By around the two-year mark (Week 108), the reported average change was a reduction of approximately 10.7 headache days per 28-day period compared to that starting point. An earlier measurement at around Week 60 (roughly 14 months in) showed a reported average reduction of about 9.2 headache days per 28-day period from baseline. The reported data also shows results from a questionnaire called the HIT-6, which scores how much headaches affect a person's life — with 36 meaning no impact and 78 meaning the worst possible impact. Participants started with an average score of 64.7. The reported data shows average score reductions of 6.8 points at one time point and 7.1 points at another, with a lower score meaning less reported impact on daily life. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00286078 · results posted 9 August 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 72 people in the treatment group and 68 people in the control group, for a total of 140 participants. The trial was measuring two things: how the number of migraine days per month changed after 12 weeks of treatment, and how many unwanted health events (called adverse events) occurred across both groups over 26 weeks. Not everyone finished the study — 40 people in the treatment group and 34 in the control group completed it, while 32 and 34 people respectively did not complete it. The reported data shows that, when it came to migraine days per month, the treatment group reported a reduction of 5.5 days on average from their starting point, while the control group reported a reduction of 3.9 days on average from their starting point. Regarding unwanted health events recorded over 26 weeks, the reported data shows 276 events were recorded in the treatment group and 284 events in the control group. No further detail about the nature of those events was included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00216736 · results posted 30 April 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 63 people in total — 32 in the placebo group and 31 in the dexamethasone (a type of steroid medication) group. Nearly all participants completed the trial (31 and 30 respectively, with one person from each group not finishing). The trial was looking at whether people who had been treated for migraine in an emergency setting and sent home pain-free went on to have their headache return within 48 hours. Participants were followed up by phone call after they left hospital. The reported data shows the following numbers for the main outcomes: When looking only at those who left hospital pain-free, 13 out of the placebo group and 14 out of the dexamethasone group reported their headache came back within 48 hours. When looking at all participants (not just those discharged pain-free), 12 people in the placebo group and 8 people in the dexamethasone group reported a returning headache within 48 hours. For the secondary outcome — how many people needed to take extra pain relief within 48 hours — 19 from the placebo group and 18 from the dexamethasone group reported doing so. A further analysis (done after the main study plan, looking at a smaller subgroup whose migraine had lasted less than 24 hours) reported that 9 placebo participants and 3 dexamethasone participants had a returning headache within 48 hours. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00719134 · results posted 9 April 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 76 participants, all of whom were grouped together rather than split into separate treatment groups. Of those, 66 completed the study and 10 did not finish. The trial was looking at how headache intensity changed over time, comparing a pain score taken 30 minutes after a headache started to a score taken 2 hours later. Pain was measured on a scale from 0 (no pain at all) to 10 (the worst pain imaginable). The reported data shows that for the primary measure — the change in headache intensity — two figures were recorded: a reduction of 47.6% in one set of measurements and a reduction of 20.7% in another. Because the data as submitted does not clearly label what each of these two figures separately represents, it is not possible to describe exactly what each number refers to beyond what is stated above. For the secondary measure, the reported data shows that 25.5% of participants reported being completely pain-free at 2.5 hours after their headache began in one set of measurements, compared to 6.6% in the other. Again, the specific labels for each of these two figures were not included in the submitted data. It is worth noting that the trial appeared to involve a single group of participants rather than a comparison between two different treatments or a placebo, though the presence of two figures for each outcome measure may suggest different conditions or time points that were not fully described in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01315847 · results posted 24 October 2014

According to the results reported on ClinicalTrials.gov, this trial involved two small groups of participants: 5 healthy volunteers (Part I) and 4 people who experience migraines (Part III). The trial was measuring two main things — how many participants experienced adverse events (that is, any unwanted or unexpected changes in their body during the study), and how much a drug called telcagepant occupied certain receptors in the brain known as CGRP receptors. To look at the brain receptors, researchers used a specialised imaging technique called a PET scan, along with a radioactive tracer called [11C]MK-4232 that can highlight where in the brain these receptors are located. Participants received either a high dose (1,120 mg) or a standard therapeutic dose (140 mg) of telcagepant. The reported data shows that 4 out of 5 healthy participants in Part I experienced at least one adverse event, and all 4 migraine participants in Part III also had at least one adverse event recorded. Regarding the brain receptor measurements, after the high dose of telcagepant (1,120 mg), the reported receptor occupancy figures for the three healthy participants who were assessed were 43%, 48%, and 58% — meaning the drug appeared to be occupying roughly that proportion of the measured brain receptors in each person. After the standard therapeutic dose (140 mg), the reported receptor occupancy figures for the three participants were much lower: 5%, 10%, and 4%. The average blood levels of telcagepant during the PET scans were also recorded for each participant, but no results for the receptor occupancy measurements in the migraine group (Part III) appear to have been reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01687088 · results posted 24 October 2014

According to the results reported on ClinicalTrials.gov, this trial involved 100 people in total — 50 people who experience chronic migraines and 50 people without migraines (the "controls"). All 100 participants completed the study with no drop-outs. The trial was measuring sense of smell using a standardised test called the University of Pennsylvania Smell Identification Test (UPSIT). This test involves identifying 40 different smells, with a higher score (out of 40) meaning a better ability to identify smells. The migraine group took the test twice — once in a clinic without a headache, and again at home during a migraine attack. The control group also took the test twice, once in the clinic and once at home about two weeks later. The reported data shows the following UPSIT scores: the chronic migraine group scored 34.5 at their first test (in the clinic, headache-free) and 34.7 at their second test (at home, during a migraine). The control group scored 35.9 at their first test and 36.1 at their second test. These are the average scores recorded for each group at each time point. No additional outcome measures beyond these scores were reported in the structured data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01125774 · results posted 3 October 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01125774) enrolled over 4,500 participants across four groups, though the main comparison was between people who received telcagepant 140 mg (around 3,018 enrolled, 2,638 treated) and those who received a placebo — a dummy treatment with no active ingredient (around 1,502 enrolled, 1,322 treated). A smaller number of participants who had taken part in a related trial were tracked separately. The trial was primarily focused on monitoring and counting any unwanted health changes — called adverse events — that participants experienced during the study, as well as tracking headache days per month in a specific group of participants who experience migraines linked to their menstrual cycle. The reported data shows that, among those who received telcagepant, 1,582 participants experienced a clinical adverse event (an unwanted change noticed during a check-up or reported by the participant), compared with 804 in the placebo group. A total of 66 people in the telcagepant group left the study due to a clinical adverse event, compared with 36 in the placebo group. For adverse events picked up through laboratory tests — such as blood or urine tests — 76 participants in the telcagepant group were affected versus 30 in the placebo group, and 8 versus 2 participants respectively left the study because of a laboratory adverse event. Regarding monthly headache days in participants with menstrual-cycle-related migraines who had five or more moderate-to-severe migraines per month at the start of the study, the reported data shows an average of 8.8 headache days per month in the telcagepant group compared with 9.3 days in the placebo group. In a more specific subgroup — those whose migraines occurred both around their period and at other times of the month — the reported figures were 9.3 days per month for telcagepant and 9.6 days for placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00781456 · results posted 29 August 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 58 people in the levonorgestrel (a hormonal contraceptive) group and 51 people in the placebo (dummy pill) group, for a total of 109 participants. The trial was measuring whether a 91-day levonorgestrel oral contraceptive pill could reduce how often participants experienced migraines, compared to a placebo. Participants kept a diary recording their migraines throughout a baseline period and then across the 91-day treatment period. The reported data shows that for the main question the trial was designed to answer — the percentage of people whose migraines dropped by at least half over the full 91-day treatment period — the numbers were nearly identical between the two groups: approximately 48.1% in the levonorgestrel group and 48.9% in the placebo group. When the trial looked at individual months, the reported figures varied: in month one, around 42.6% (levonorgestrel) versus 37.8% (placebo) had at least a 50% reduction; in month two, around 62.7% versus 52.3%; and in month three, around 60.0% versus 64.9%. The reported data also shows that average migraine severity scores (on a 0–3 scale) decreased from baseline in both groups across all time points, with reductions ranging from about −0.37 to −1.06 in the levonorgestrel group and −0.18 to −0.72 in the placebo group. Changes in a standard migraine disability score (MIDAS) were reported as −7.8 for levonorgestrel and −8.5 for placebo. A headache impact questionnaire (HIT-6) was also planned, but the trial reported an administration error meant the full score could not be calculated, so those results were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00443209 · results posted 18 August 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 712 people in the telcagepant group and 356 in the rizatriptan group at the start of the main 12-month period. The study was comparing two migraine medications — telcagepant (at doses of 280 mg or 300 mg) and rizatriptan (10 mg) — and was primarily focused on tracking certain unwanted experiences (called adverse events) that participants reported while taking the drugs over up to 18 months. A smaller group of participants continued into a second period lasting from month 13 to 18. The reported data shows that for a specific group of unwanted experiences linked to triptan-type medications (such as chest pain, chest tightness, pins and needles, or unusual skin sensations), 5.0% of participants in the telcagepant group reported at least one, compared with 11.2% in the rizatriptan group. For broader unwanted experiences identified through physical check-ups, 58.7% of telcagepant participants and 63.9% of rizatriptan participants reported at least one. Unwanted changes picked up through laboratory tests were reported by 1.9% of the telcagepant group and 1.6% of the rizatriptan group. Readings outside pre-set limits for vital signs (such as blood pressure, pulse and temperature) were reported by very small percentages in both groups, generally below 2% across all measures. As a secondary outcome — meaning a second question the trial was looking at — the reported data shows that in 38.9% of migraine attacks treated with telcagepant, participants reported being completely free of pain at 2 hours after taking the dose, compared with 47.5% of attacks treated with rizatriptan. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00758836 · results posted 11 August 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 683 adults across four groups to compare different treatments for migraine headaches. The groups were: a placebo (dummy treatment), telcagepant 280 mg combined with ibuprofen 400 mg, telcagepant 280 mg combined with paracetamol (APAP) 1000 mg, and telcagepant 280 mg on its own. Telcagepant is a type of migraine medication. Of those enrolled, 563 participants actually received a treatment and completed the study. The trial was primarily measuring how many people became completely pain-free two hours after taking their dose, as well as tracking any unwanted health changes (called adverse events) that occurred in the 48 hours and 14 days following the dose. The reported data shows that, for the main pain outcome at two hours, 10.9% of placebo participants reported being completely pain-free, compared with 35.2% in the telcagepant-plus-ibuprofen group, 38.3% in the telcagepant-plus-paracetamol group, and 31.2% in the telcagepant-alone group. For the secondary outcome — pain relief (meaning pain dropped to mild or none, not necessarily zero) — the reported figures were 30.6% for placebo, 71.0% for telcagepant plus ibuprofen, 69.9% for telcagepant plus paracetamol, and 65.2% for telcagepant alone. Regarding adverse events within 48 hours, the reported data shows 27 placebo participants experienced at least one unwanted health change, compared to 44, 42, and 34 participants in the three telcagepant groups respectively. Within 14 days, those numbers were 31, 46, 46, and 37 participants across the same groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00329771 · results posted 21 April 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 28 people who experience episodic migraines (meaning migraines that occur occasionally rather than on most days). Of those 28 participants, 25 completed the study and 3 did not. The trial was measuring how many of these people experienced a condition called **allodynia** during a migraine attack — this is when normal, gentle sensations (like a light brush on the skin) feel uncomfortable or even painful. Allodynia was tested by lightly brushing specific spots on the head, neck, and forearms, and participants rated any discomfort on a scale from "normal sensation" to "extremely painful or unpleasant." The reported data shows that out of the participants, **15 people** were recorded as experiencing allodynia during a migraine attack based on this brushing test and rating scale. No additional breakdown of the scale scores or any secondary outcome measures appear to have been reported in the structured data submitted to ClinicalTrials.gov. It is worth noting that this trial had only one small group and no comparison group, so the reported number reflects observations within this single set of participants only. Any figures beyond what is described above were not reported in the available data, so no further conclusions can be drawn from this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00904150 · results posted 24 February 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled women in two groups: 285 women who experienced menstrual migraines (migraines linked to their period) and 300 women who did not get migraines. The study was looking at whether certain variations in genes — particularly genes related to the hormones oestrogen and progesterone — appeared more or less often in women with menstrual migraines compared to women without migraines. A smaller subset of participants also provided blood samples at two points in their menstrual cycle (the follicular phase, early in the cycle, and the luteal phase, later in the cycle) to look at how those genes were being "switched on or off" in the body. The reported data shows the following counts for the gene variants tested. For the progesterone receptor gene variation (PROGINS), the menstrual migraine group had 208, 64, and 8 participants across the three possible gene patterns, while the no-migraine group had 112, 39, and 2. For two oestrogen receptor gene variations (ESR1 G594A and ESR1 C325G), similar breakdowns were recorded across both groups. For a gene called TNF (linked to inflammation), the reported numbers across three gene patterns were 1, 40, and 149 in the migraine group, and 2, 20, and 32 in the no-migraine group. For a gene called SYNE1, the counts were 24, 102, and 89 in the migraine group, and 25, 54, and 40 in the no-migraine group. Regarding how actively the progesterone and oestrogen receptor genes were being expressed (switched on) in blood samples, the reported data shows figures ranging roughly between 8.69 and 16.73 (measured in number of genes expressed) across both groups and both phases of the cycle, with no figures notably absent from the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00850421 · results posted 18 September 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people who experienced episodic migraine headaches. All participants received injections of Botulinum Toxin Type A (commonly known as BOTOX). The trial was designed to look at three things: whether the injections changed how much healthcare people used (such as doctor visits or medications), whether participants' quality of life changed, and whether the frequency and intensity of their migraine episodes changed. The reported data shows that, unfortunately, no numerical results were submitted for any of the three outcome measures — not for healthcare resource use, quality of life, or migraine frequency and intensity. Of the 35 people who started the trial, 18 completed it and 17 did not complete it, but no measurement data was reported for either group. This means it is not possible to describe what the numbers showed for any of the things the trial set out to measure. Because no outcome data was provided in the submission to ClinicalTrials.gov, no conclusions can be drawn from this trial about any of its intended measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00355394 · results posted 30 August 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people in total — 15 received a placebo (an inactive treatment) and 16 received metoclopramide, a medicine sometimes used for nausea and headaches. All 31 participants completed the trial with no drop-outs. The trial was measuring headache intensity using a zero-to-ten scale called the Numeric Rating Scale (NRS), where zero means no headache at all and ten means the worst possible headache. The main thing the trial was looking at was how many people in each group reported a score of zero — meaning complete absence of headache — at the two-hour mark. The reported data shows that at two hours, 12 out of 16 participants in the metoclopramide group reported a headache score of zero, compared with 5 out of 15 in the placebo group. At one hour, the reported numbers were 9 out of 16 for metoclopramide and 1 out of 15 for placebo. At 24 hours, 7 out of 16 in the metoclopramide group and 4 out of 15 in the placebo group reported a score of zero. The reported data also shows average changes in headache scores from the start of the trial: at one hour, the metoclopramide group's average score dropped by 6.8 points compared with a drop of 2.5 points in the placebo group; at two hours, the drops were 7.8 and 4.9 points respectively; and at 24 hours, the drops were 5.6 and 4.5 points respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01060111 · results posted 6 August 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 245 people in total across three groups: 81 in the "Topiramate Standard" group, 84 in the "Topiramate Slow" group, and 80 in the "Topiramate Slow and Propranolol Booster" group. The trial was measuring changes in migraine frequency, migraine-related disability, and pain intensity across these three different treatment approaches. Not everyone who started the trial finished it — 54, 61, and 45 people completed the study in each respective group. The reported data shows that the main thing being measured was the percentage reduction in migraine episodes compared to each person's starting point (their "baseline"). The Topiramate Standard group showed a reported 48% decrease in migraine episodes, the Topiramate Slow group showed a 57% decrease, and the Topiramate Slow and Propranolol Booster group showed a 46% decrease. For the secondary measurements taken at Week 6, the reported data shows reductions in how often migraines occurred each week across all three groups, along with reductions in scores on two scales — one measuring how much migraines were interfering with daily life (the MIDAS scale, where higher numbers mean more disruption), and one measuring pain intensity on a 0–10 scale (where 0 means no headache and 10 means the worst imaginable headache). All three groups showed reported reductions on both of these scales at Week 6, though the exact baseline figures for the secondary outcomes were not clearly separated in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01799590 · results posted 6 May 2013

According to the results reported on ClinicalTrials.gov, this trial (NCT01799590) involved 296 participants in total, split across three groups: 111 people received a placebo that could later be switched to the study drug (topiramate, brand name JNS019), 94 received a 50 mg dose of topiramate, and 91 received a 100 mg dose. The trial was measuring the number of participants who experienced any unwanted medical events (called "adverse events") as its main focus, and also tracked several migraine-related counts — including how many migraine attacks and headache days participants had each month — before and during treatment. The reported data shows that, for the primary measure of adverse events, 110 out of 111 people in the placebo/topiramate group, 85 out of 94 in the 50 mg group, and 79 out of 91 in the 100 mg group had at least one adverse event recorded. It is important to note that an adverse event in this context simply means any unwanted medical occurrence during the trial — it does not necessarily mean the event was caused by the study drug. For the secondary measures, the reported data shows that before the treatment period, participants across all three groups averaged roughly 6–7.5 migraine-related days or attacks per month depending on how they were counted. During the treatment period, the reported changes from those starting figures ranged from a reduction of about 1.0 to 2.6 per month across the different groups and different counting methods, with the placebo/topiramate group generally showing reductions in a similar range to the active-dose groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01081795 · results posted 6 May 2013

According to the results reported on ClinicalTrials.gov, this trial (NCT01081795) involved 387 adults who experienced migraines. Participants were divided into three groups: one group took a 50 mg dose of topiramate (brand name JNS019), one group took a 100 mg dose of topiramate, and one group took a placebo (a dummy pill with no active ingredient). The trial ran for six months and was primarily measuring whether the number of migraine attacks per month changed from the start of the trial to the end. The reported data shows that, at the start of the trial, participants were experiencing roughly 5.9 to 6.6 migraine attacks per month on average across the three groups. After six months, the reported data shows the average number of monthly migraine attacks had changed by -0.9 in the 50 mg topiramate group (meaning about one fewer attack per month), -1.2 in the 100 mg topiramate group, and -1.0 in the placebo group. In other words, all three groups — including those taking the dummy pill — reported a small reduction in monthly migraine attacks. The secondary measures, which tracked things like headache days and migraine attack days at each month, also showed small reductions across all three groups, with the numbers reported being broadly similar between the active treatment groups and the placebo group throughout the six months. It is worth noting that the trial measured several things using slightly different counting methods (for example, different rules for what counts as one versus two migraine attacks), and the reported data shows small differences between groups depending on which counting method was used. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00747812 · results posted 3 August 2012

According to the results reported on ClinicalTrials.gov, this trial looked at a brain stimulation technique for headaches, comparing "active stimulation" (the actual treatment) against "sham stimulation" (a dummy or placebo version of the procedure). A total of 8 people took part — 5 in the active stimulation group and 3 in the sham stimulation group. The trial was measuring two things: the total number of hours participants experienced headaches, and the number of days on which they had headaches lasting four or more hours. The reported data shows that none of the 8 participants completed the study — all 8 are listed as "not completed." Because of this, the results for both primary outcome measures (hours of headache and days with long headaches) are listed as "NA," meaning no data was reported for either the active stimulation group or the sham stimulation group. In other words, no outcome numbers are available from this trial. Given that the trial did not reach completion and no outcome figures were recorded, the reported data does not provide any numbers about what happened to participants' headaches under either condition. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01001234 · results posted 8 May 2012

According to the results reported on ClinicalTrials.gov, this trial looked at rizatriptan — a tablet used for migraines — compared to a placebo (a dummy treatment with no active ingredient) in children and teenagers aged 6 to 17 who were experiencing a migraine attack. A total of 1,382 participants were enrolled across five groups at the start of the study, though the number who actually received a treatment dose and completed the trial varied by group. The trial used a two-stage design and measured pain using a simple five-face picture scale, where 1 meant no pain and 5 meant very bad pain. The main thing being measured was whether participants aged 12–17 had completely no pain two hours after taking their second dose. The reported data shows that for the primary outcome — complete pain freedom at two hours in the 12–17 age group — 87 out of 197 participants in the rizatriptan group and 63 out of 223 participants in the placebo group reported no pain at that time point. For the secondary outcome of pain relief (meaning pain dropped to mild or no pain) in the same age group, the reported data shows 167 out of 284 in the rizatriptan group and 147 out of 286 in the placebo group reached that level. For the broader 6–17 age group, the reported data shows 126 out of 382 rizatriptan participants and 94 out of 388 placebo participants reported complete pain freedom at two hours, while 220 out of 382 rizatriptan participants and 204 out of 388 placebo participants reported pain relief. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01004263 · results posted 4 May 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 606 participants, all of whom received rizatriptan, a medication used to treat migraine attacks. The study followed participants for up to 12 months and was specifically designed to track unwanted or unexpected changes in health (called "adverse events") that occurred after taking the medication, as well as to measure how many migraine attacks resulted in complete pain relief within two hours of taking a dose. There was only one group in the trial — no comparison or placebo group was used. The reported data shows that, out of 606 participants who started the trial, 322 experienced at least one adverse event within 24 hours of taking any dose, and 400 experienced at least one adverse event within 14 days of taking any dose. These numbers count each person only once, regardless of how many events they may have had. The reported data also shows that 4 participants left the trial due to an adverse event occurring within 24 hours of a dose, and 14 participants left the trial due to an adverse event occurring within 14 days of a dose. By the end of the study, 427 participants had completed it, while 179 did not finish. For the secondary outcome, the reported data shows that, on average across all participants, about 46.3% of their individual migraine attacks resulted in complete pain freedom (a drop to "no pain" on the scale used) at two hours after taking a dose. This figure represents an average calculated first for each person and then across all participants, so individual experiences varied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00772031 · results posted 19 January 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 191 people in total — 96 in a group taking topiramate plus propranolol, and 95 in a group taking topiramate plus a placebo (a dummy pill with no active ingredient). Both groups were already taking topiramate, a medicine sometimes used for migraines, and the trial was looking at whether adding propranolol (another medicine) made any difference. The main thing being measured was how much the number of moderate-to-severe headache days changed over a 28-day period after six months of treatment, compared to where each person started. By the end of the study, 64 people in the first group and 52 in the second group had completed the trial. The reported data shows that, on average, people in the topiramate-plus-propranolol group had 4.4 fewer moderate-to-severe headache days per 28-day period compared to their starting point, while people in the topiramate-plus-placebo group had 4.7 fewer days. For the secondary measures, 37 participants in the combination group and 28 in the placebo group had at least a 30% reduction in headache days; 26 versus 23 participants had at least a 50% reduction. The reported data also shows small changes in depression scores (measured on a 0–21 scale), with the combination group changing by +0.3 points and the placebo group by +0.6 points from their starting scores. On a disability scale (MIDAS, ranging from 0–270, where higher scores mean more disability), both groups showed a small decrease: −3.18 for the combination group and −3.46 for the placebo group. A quality-of-life measure called the Role Restrictive domain (scored 0–100, where lower is worse) changed by −0.7 in the combination group and −2.2 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00963937 · results posted 26 August 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 178 participants across three groups: 89 received a placebo (a dummy treatment with no active ingredient), 44 received sumatriptan 25 mg, and 45 received sumatriptan 50 mg. The trial was measuring how migraine pain and associated symptoms — such as nausea, sensitivity to light, and sensitivity to sound — changed over time after taking the treatment. Pain was rated by participants themselves on a five-point scale, from "none" through to "severe." The reported data shows that for the main outcome — the percentage of participants who experienced meaningful pain relief two hours after treatment — 38.6% of the placebo group and 31.1% of the combined sumatriptan group (both doses added together) reached that point. For being completely pain-free at two hours, the reported figures were 28.6% in the placebo group, 24.2% in the sumatriptan 25 mg group, and 19.5% in the sumatriptan 50 mg group. The reported data also shows results for associated symptoms at two hours: for light sensitivity, 52.8% of the placebo group and 53.6% of the combined sumatriptan group reported no symptoms; for sound sensitivity, 63.6% of the placebo group and 53.3% of the combined sumatriptan group reported no symptoms; and for nausea, 81.0% of the placebo group and 61.1% of the combined sumatriptan group reported no symptoms. The data for the 240-minute (four-hour) time point was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00203307 · results posted 10 August 2011

According to the results reported on ClinicalTrials.gov, this was a small crossover trial — meaning participants tried both treatments at different times — comparing the medication olanzapine against a placebo (a dummy treatment with no active ingredient) for migraine headaches. The trial enrolled a very small number of people: 3 participants were assigned to receive olanzapine first and then switch to placebo, while no participants were recorded in the "placebo first" group. Of the 3 who started, only 1 completed both periods of the trial. The reported data shows that the primary outcome — the difference in the number of migraine headache periods (each counted as a 24-hour block when a migraine was present) between the olanzapine period and the placebo period — was reported as zero for the olanzapine-first group. No data was reported for the placebo-first group. For the two secondary outcomes, which looked at changes in the frequency of individual migraine attacks and changes in the number of days participants used other headache treatments, no results data was reported at all. Because so few people took part and completed the trial, and because much of the data was not reported, the results as submitted are very limited. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00846495 · results posted 9 August 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 55 people with migraines — 28 in the topiramate group and 27 in the frovatriptan group. Topiramate is a daily preventive tablet, while frovatriptan was used as a "preemptive" treatment, meaning it was taken around the time a migraine was expected (for example, around the menstrual cycle) rather than every day. The trial compared how many migraine attacks and headache days each group experienced over two months of treatment. The reported data shows that during the second month of treatment, the topiramate group recorded an average of 1.35 migraine attacks compared to 2.12 in the frovatriptan group. For headache days in that same period, the topiramate group reported an average of 4.75 days, while the frovatriptan group reported 2.79 days. For a secondary measure looking at participants who had more than a 50% drop in migraine attacks or headache days, the reported numbers were broadly similar between the two groups across both treatment months. The trial also measured quality of life using a questionnaire scored from 0 to 100 (higher meaning better), and participant satisfaction using another questionnaire on the same scale — both groups showed scores reported across multiple time points and dimensions, with results varying by category and time point. The reported data shows that not all participants completed the trial — 8 people in the topiramate group and 3 in the frovatriptan group did not finish. The reasons for not completing were not detailed in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01286207 · results posted 10 June 2011

According to the results reported on ClinicalTrials.gov, this trial involved 1,959 participants in total — 751 in the Rizatriptan 5 mg group, 857 in the Rizatriptan 10 mg group, and 351 in a Standard Care group. The trial was measuring two main things: how often people experienced headache pain relief within two hours of taking their assigned treatment, and how often participants experienced various types of adverse events (unwanted medical occurrences) during the study. Not everyone who started the trial finished it — around 298, 248, and 90 participants respectively did not complete the study across the three groups. The reported data shows that, looking at headache pain relief at two hours (measured by a reduction on a headache severity scale), 80% of headaches in the Rizatriptan 5 mg group, 89.5% in the Rizatriptan 10 mg group, and 69.6% in the Standard Care group met the definition of "pain relief." Regarding adverse events, the reported data shows that serious adverse events were recorded for 13 participants in the 5 mg group, 17 in the 10 mg group, and 10 in the Standard Care group. Adverse events that investigators considered to be related to the study drug were recorded for 288 participants in the 5 mg group, 456 in the 10 mg group, and 139 in the Standard Care group. The number of participants who stopped taking part because of an adverse event was 26, 37, and 7 respectively. Additionally, adverse changes in laboratory test results considered drug-related were reported for 15, 23, and 4 participants across the three groups. It is worth noting that some of the adverse event data appears to include two separate sets of figures per group — the reported data does not fully clarify what each set represents, so those additional figures have not been included here to avoid any misrepresentation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00897949 · results posted 4 May 2011

According to the results reported on ClinicalTrials.gov, this trial looked at rizatriptan — a medication used for migraines — in two different doses (5 mg and 10 mg) compared to a placebo (a dummy pill with no active ingredient). A total of 1,473 people were enrolled across the three groups: 554 in the 5 mg group, 549 in the 10 mg group, and 370 in the placebo group. Of those, the numbers who actually took a dose of the trial medication were 458, 456, and 304 respectively. The trial's main focus was on how many participants reported their headache pain reducing from a moderate or severe level down to mild or none within two hours of taking the medication. The reported data shows that for this main measure, 285 out of 457 participants in the 5 mg group and 322 out of 455 in the 10 mg group reported that level of pain reduction at two hours, compared with 106 out of 302 in the placebo group. For the secondary measures — which were additional things the trial tracked — the reported data shows that being completely pain-free at two hours was recorded for 150 people in the 5 mg group, 193 in the 10 mg group, and 30 in the placebo group. Regarding daily functioning, 175 (5 mg), 209 (10 mg), and 54 (placebo) participants reported no disability at the two-hour mark. The reported data also shows that 101 people in the 5 mg group, 76 in the 10 mg group, and 128 in the placebo group took additional "escape" medication (extra pain relief) within two hours, meaning they needed something more. For those whose headache came back within 24 hours and who then took a second dose, the numbers reporting pain relief after that second dose varied across the different dose combinations, with figures ranging from 12 to 53 participants reporting relief depending on the combination used. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00894556 · results posted 20 January 2011

According to the results reported on ClinicalTrials.gov, this trial looked at a migraine medication called rizatriptan. The trial had two phases. First, 194 people went through a baseline phase (where a comparison treatment, sumatriptan, was tested), and 109 of those completed it. Then 109 participants moved into the main treatment phase, split across three groups that each received a mix of rizatriptan and placebo (a dummy treatment with no active ingredient) across multiple migraine attacks. A total of 100 of these participants completed the treatment phase. The trial was measuring how well rizatriptan reduced headache pain compared to placebo. The reported data shows two main things that were measured. The first was called "pain relief" — this meant a person's headache went from moderate or severe down to mild or no pain after taking the treatment. According to the results reported on ClinicalTrials.gov, out of the attacks where rizatriptan was taken, 102 attacks resulted in pain relief, compared to 21 attacks where placebo was taken — though the total number of attacks in each group was also reported as 100 and 78 respectively. The second measure was "pain freedom," meaning the headache went away completely (no pain at all). The reported data shows this occurred in 46 attacks treated with rizatriptan, compared to 12 attacks treated with placebo, out of a total of 156 and 87 attacks respectively in each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00168428 · results posted 7 December 2010

According to the results reported on ClinicalTrials.gov, this trial looked at whether injections of Botulinum Toxin Type A (sometimes known by brand names like Botox) compared to a dummy injection (salt water/saline) could reduce the number of headache days in people with chronic migraines. A total of 347 people were assigned to the Botulinum Toxin Type A group and 358 to the placebo (saline) group in the first, blinded phase of the trial — meaning neither participants nor researchers knew who received which treatment during that stage. The reported data shows that, at the start of the trial, participants in both groups were experiencing roughly 19–20 headache days in every 28-day period. By week 24, the Botulinum Toxin Type A group reported an average reduction of 9.0 headache days per 28-day period, while the placebo group reported an average reduction of 6.7 days. For total hours spent with a headache, the reported figures showed an average reduction of around 132 hours for the Botulinum Toxin Type A group compared to around 90 hours for the placebo group. Similar patterns were reported across other measures — including days with moderate or severe headache, days meeting migraine criteria, and number of separate headache episodes — with the Botulinum Toxin Type A group showing somewhat larger average reductions in each case. Regarding the impact of headaches on daily life (measured using a standard questionnaire called the HIT-6), the reported data shows that 66.3% of the Botulinum Toxin Type A group still fell into the "severe impact" category at week 24, compared with 76.5% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00156910 · results posted 7 December 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 341 people in the Botulinum Toxin Type A group and 338 people in the Placebo (saline injection) group for the initial double-blind phase, where neither participants nor researchers knew who received which treatment. The trial was measuring whether Botulinum Toxin Type A reduced the frequency of headache episodes, headache days, and the number of times participants took pain relief medication, over a 28-day period around the 24-week mark. Participants had to have headaches lasting at least 4 continuous hours to have them counted. The reported data shows that, for the primary measure — the number of headache episodes in a 28-day period — participants in the Botulinum Toxin Type A group started with an average of about 12.3 episodes and reported a reduction of 5.2 episodes by around week 24. The placebo group started at about 13.4 episodes and reported a reduction of 5.3 episodes. For secondary measures, headache days reduced by an average of 7.8 days in the Botulinum Toxin Type A group (from a starting point of 20.0 days) compared with 6.4 days in the placebo group (from 19.8 days). Days with migraine or probable migraine reduced by 7.6 in the Botulinum Toxin Type A group versus 6.1 in the placebo group. The number of times participants took acute pain medication reduced by about 10.3 in the Botulinum Toxin Type A group and 10.4 in the placebo group. The reported data shows that both groups experienced reductions across all measured outcomes, with the starting figures and changes being broadly similar between the two groups across most measures. No data on side effects or safety outcomes was included in the structured results submitted to ClinicalTrials.gov, so those figures are not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00792636 · results posted 4 November 2010

According to the results reported on ClinicalTrials.gov, this trial (NCT00792636) enrolled 407 people in total, split across three groups: 135 received a combination of sumatriptan and naproxen, 136 received sumatriptan alone, and 136 received naproxen alone. The trial was measuring changes in blood pressure — both the "top" number (systolic) and "bottom" number (diastolic) — over six months of treatment. Participants measured their own blood pressure at home using a special monitor that sent readings to a central system. The number who completed the study was considerably lower than those who started: 67 in the combination group, and 55 each in the other two groups. The reported data shows that for the primary measure — the combination sumatriptan/naproxen group — the average systolic (top) blood pressure started at around 111.7 mmHg (millimetres of mercury, the standard unit for blood pressure) and was recorded at around 107.1 mmHg at six months, a reported change of approximately −2.9 mmHg. The average diastolic (bottom) blood pressure started at around 76.0 mmHg and was recorded at around 73.0 mmHg at six months, a reported change of approximately −2.1 mmHg. For comparison, the reported data shows the sumatriptan-alone group had systolic and diastolic changes of −2.8 mmHg and −1.6 mmHg respectively, while the naproxen-alone group had changes of −1.8 mmHg and −0.6 mmHg respectively. Additional secondary analyses looked at subgroups based on how frequently participants used the medication per migraine and how many migraines they had per month; those reported changes ranged from roughly −0.3 to −5.3 mmHg for systolic and −0.4 to −4.1 mmHg for diastolic pressure, though some subgroup figures were not fully calculable due to limitations in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00899379 · results posted 15 July 2010

According to the results reported on ClinicalTrials.gov, this trial involved 473 people in total (across five groups ranging from 94 to 95 participants each). The trial was looking at a migraine medicine called rizatriptan 10 mg compared to a placebo (a dummy treatment with no active ingredient). Each participant was assigned to treat up to four separate migraine attacks, and for each attack they received either rizatriptan or placebo according to their group's schedule. The trial was measuring how many people experienced pain relief two hours after taking their assigned treatment — defined as headache severity dropping from moderate or severe down to mild or none. The reported data shows the following numbers for people who reported pain relief at two hours after dosing. For the **first migraine attack**, 74 out of 246 people in the rizatriptan group and 52 out of 30 people in the placebo group reported pain relief. (Note: the placebo group's total of 30 participants appears very small relative to the 52 reporting relief, which may reflect how this crossover trial counted results — the data is reported as submitted.) For the **second attack**, 63 of 228 rizatriptan-treated participants and 46 of 27 placebo participants reported pain relief. For the **third attack**, 52 of 207 (rizatriptan) and 54 of 21 (placebo) reported pain relief. For the **fourth attack**, 65 of 190 (rizatriptan) and 26 of 31 (placebo) reported pain relief. It is worth noting that some of these figures — particularly where the number reporting relief appears to exceed the group total — may reflect the crossover nature of the study design, and no further breakdown was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00397254 · results posted 22 September 2009

According to the results reported on ClinicalTrials.gov, this trial involved 155 people who experienced migraines. Participants were split into two groups: 79 people who were given access to up to 27 tablets of rizatriptan (a migraine medication) per month — described as the "clinical limit" — and 76 people who were given access to up to 9 tablets per month — described as the "formulary limit" (meaning the amount typically covered by a prescription plan). The trial was measuring whether the number of tablets available to a person made a difference to how their migraines played out, looking at things like how many migraine days they had, how long attacks lasted, and how severe the pain was. The reported data shows that for the primary outcome — the number of days with a migraine — the clinical limit group recorded an average of about 2.7 days, while the formulary limit group also recorded an average of about 2.7 days. For secondary outcomes, the reported number of migraine attacks was approximately 4.9 in the clinical limit group and 4.4 in the formulary limit group. Average attack duration was reported as around 11.6 hours in the clinical limit group and 12.9 hours in the formulary limit group. Headache severity, rated on a scale of 0 (no pain) to 3 (severe pain), was reported as 1.50 in the clinical limit group and 1.59 in the formulary limit group. The reported data also shows that about 7.8% of people in the clinical limit group and 2.7% in the formulary limit group were classed as "responders" — meaning they experienced at least a 50% drop in how often their attacks occurred. For the proportion of attacks where all associated symptoms had disappeared two hours after taking the medication, the clinical limit group reported approximately 58% of attacks and the formulary limit group reported approximately 57% of attacks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT00910689 · results posted 1 June 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 232 people in total across four groups. All participants first went through a one-month run-in period receiving what the trial called "Optimal Acute Therapy" (OAT — standard migraine treatment taken when a migraine strikes). They were then assigned to one of four combinations: OAT plus a placebo; OAT plus a beta blocker (a type of preventive medication); OAT plus a behavioural/lifestyle programme (referred to as BMM) plus placebo; or OAT plus BMM plus a beta blocker. The trial measured changes in how often migraines occurred, how many days were affected by migraine, and participants' quality of life — all compared against each person's own starting point at the end of the run-in month. The reported data shows the following changes in the average number of migraine episodes per 30 days by Month 10: the OAT-plus-placebo group reported a reduction of 2.1 episodes; the OAT-plus-beta-blocker group also reported a reduction of 2.1 episodes; the OAT-plus-BMM-plus-placebo group reported a reduction of 2.2 episodes; and the OAT-plus-BMM-plus-beta-blocker group reported a reduction of 3.3 episodes. For migraine days per 30 days at Month 10, the reported reductions were 3.3 days, 3.9 days, 3.3 days, and 5.4 days respectively. A quality-of-life questionnaire was also used (scored 14–84, where higher scores mean greater impact on daily life); the reported reductions in score at Month 10 were 7.1, 7.1, 8.6, and 13.0 points across the four groups. By Month 16, the reported data shows similar patterns: migraine episode reductions of 2.5, 2.5, 2.7, and 3.8; migraine day reductions of 3.9, 4.5, 4.1, and 6.1; and quality-of-life score reductions of 8.8, 8.5, 9.6, and 15.2 across the four groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT00516737 · results posted 14 April 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 207 participants in total — 103 received rizatriptan 10 mg (an orally dissolving tablet, or ODT) and 104 received a placebo (a dummy tablet with no active ingredient). The trial was measuring how many people were free of migraine pain two hours after taking their tablet, along with a number of other outcomes over the following 24 hours, including whether participants needed extra ("rescue") medication and whether symptoms such as nausea, sensitivity to light (photophobia), and sensitivity to sound (phonophobia) were absent at two hours. The reported data shows that for the main outcome — being completely pain-free at two hours — 61 out of 103 participants in the rizatriptan group reached this point, compared with 27 out of 104 in the placebo group. For the secondary outcomes, the reported numbers were: sustained pain freedom from 2 to 24 hours (with no rescue medication needed) — 48 in the rizatriptan group versus 17 in the placebo group; no rescue medication used up to 24 hours — 61 versus 32; no sensitivity to light at 2 hours — 69 versus 43; no sensitivity to sound at 2 hours — 72 versus 55; and no nausea at 2 hours — 82 versus 73. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.