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Reported trial results for Narcolepsy

Every Narcolepsy 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.

29 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

  • NCT06505031 · results posted 16 July 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT06505031) enrolled 105 participants — 35 received a placebo and 70 received the investigational medicine oveporexton — to study its effects on narcolepsy symptoms over 12 weeks. The trial measured two main things: how long participants could stay awake during a formal wakefulness test (called the Maintenance of Wakefulness Test, or MWT), and how sleepy they felt day-to-day using a standard questionnaire called the Epworth Sleepiness Scale (ESS, scored 0–24, where higher means sleepier). A number of additional measures were also tracked, including cataplexy episodes (sudden muscle weakness attacks), attention, and overall symptom burden. The reported data shows that, on the main wakefulness test, the placebo group's average time-to-sleep-onset changed by −1.01 minutes from the start of the study, while the oveporexton group's changed by +19.09 minutes (a positive number meaning it took longer to fall asleep). On the sleepiness questionnaire, the placebo group's score changed by −1.57 points and the oveporexton group's by −11.10 points (negative meaning lower sleepiness scores). For cataplexy attacks, the reported estimated average was about 24 attacks per week in the placebo group compared with about 6 per week in the oveporexton group at week 12. On the attention test, the placebo group had 3.36 more lapses on average while the oveporexton group had 5.46 fewer. When asked about their overall impression of change, 15% of the placebo group and 90% of the oveporexton group reported being "much" or "very much" improved. Finally, on a broader narcolepsy symptom scale (scored 0–57, higher meaning worse), the placebo group's score changed by −3.04 points and the oveporexton group's by −21.15 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.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗

  • NCT05709873 · results posted 30 June 2026

    According to the results reported on ClinicalTrials.gov, this trial involved just seven people in total — four in a group receiving a therapy called Imagery Rehearsal Therapy (IRT), and three in a group receiving IRT combined with an additional technique called Targeted Dream Control (IRT+TDC). Six of the seven participants completed the study. The trial was measuring how often participants experienced nightmares, how severe those nightmares were, and also looked at anxiety symptoms, depression symptoms, how often participants acted out their dreams, and how often they talked in their sleep — all before and after the therapy period. The reported data shows the following before and after figures. For nightmare frequency (nightmares per week), the IRT group went from 12.75 down to 2.00, while the IRT+TDC group went from 4.00 down to 2.50. For nightmare severity (scored 0–37, where higher means worse), the IRT group went from 23.67 down to 12.33, and the IRT+TDC group went from 18.33 down to 5.33. For anxiety (scored on a scale where 50 is the general population average), the IRT group went from 58.80 to 56.53, and the IRT+TDC group went from 50.33 to 48.70. For depression (same type of scale), the IRT group went from 56.33 to 55.07, and the IRT+TDC group went from 50.27 to 47.37. Dream enactment episodes per week went from 2.17 to 1.00 in the IRT group, and from 1.42 to 1.17 in the IRT+TDC group. Sleep talking episodes per week went from 12.92 to 0.17 in the IRT group, and from 1.08 to 0.83 in the IRT+TDC group. It is important to note that with only seven participants overall, this was a very small study, and the numbers alone cannot tell us whether any changes were due to the therapies or other factors. 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 ↗

  • NCT05869773 · results posted 24 April 2026

    According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called JZP258 and measured its effect on blood pressure — specifically systolic blood pressure (the "top number" in a blood pressure reading, measured in millimetres of mercury, or mmHg). A total of 155 people entered an initial screening phase, of whom 67 went on to take part in the treatment period. Of those 67, 60 people completed the treatment period, while 7 did not finish. The reported data shows changes in systolic blood pressure from the start of the treatment period to the end. For the main (primary) measure — average blood pressure recorded over a full 24-hour period — the reported change was a reduction of 4.14 mmHg. The trial also measured blood pressure at different times of day as secondary outcomes. During daytime hours, the reported average reduction was 5.08 mmHg. When measured during seated rest in a clinic setting, the reported average reduction was 9.16 mmHg. During nighttime hours, the reported average reduction was 1.95 mmHg. These figures represent the average change across participants in the JZP258 group; no comparison group data was included in the submitted results. It is worth noting that the reported data does not include information about what level of change would be considered meaningful, nor does it include any comparison to a placebo or other 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.

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

  • NCT06179407 · results posted 14 April 2026

    According to the results reported on ClinicalTrials.gov, this trial involved two groups (called Panel A and Panel B), though all participants with reported data were in Panel A. Nine people started the trial. Over roughly seven weeks, participants received single doses of an investigational drug called MK-6552 at four different dose levels (0.1 mg, 0.25 mg, 0.5 mg, and 1 mg), as well as repeated daily doses over seven-day periods, and a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring how MK-6552 moves through the body — how quickly it is absorbed, how high its levels climb in the bloodstream, and how long it stays there. No primary outcome measure results were reported in the submitted data; the figures available relate only to the secondary (supporting) measures. The reported data shows the following for the single-dose phase, where two doses were given six hours apart. The peak level of MK-6552 detected in the blood (called Cmax, meaning the highest concentration reached) rose with each higher dose: 1.35 nmol/L at 0.1 mg, 3.46 nmol/L at 0.25 mg, 5.96 nmol/L at 0.5 mg, and 10.0 nmol/L at 1 mg. The time it took to reach that peak (Tmax) ranged from about half an hour at the lowest dose to just over one hour at the highest dose. A measure of the total amount of drug the body was exposed to over time (called AUC0–∞, essentially the area under a graph of drug levels over time) was reported as 7.99, 26.2, 51.8, and 106 hr·nmol/L for the 0.1 mg, 0.25 mg, 0.5 mg, and 1 mg doses respectively. For the repeated-dose periods, figures for the total drug exposure (AUC) were not reported in the submitted data, though peak concentration and concentration at specific time points (2 hours and 6 hours after dosing) were recorded across the different 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT04072380 · results posted 13 January 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04072380) tested two doses of an investigational medicine called SUVN-G3031 (2 mg and 4 mg) against a placebo (an inactive dummy treatment) in people with excessive daytime sleepiness. A total of 190 people were enrolled across the three groups — 63 in the 2 mg group, 64 in the 4 mg group, and 63 in the placebo group. The trial's main measurement was the Epworth Sleepiness Scale (ESS), a standard questionnaire where people rate how likely they are to doze off in eight everyday situations; scores run from 0 to 24, with higher scores meaning more sleepiness. The reported data shows that, from the start of the trial to its end, average ESS scores fell (improved) by 5.1 points in the 2 mg group, 5.6 points in the 4 mg group, and 3.3 points in the placebo group. For the secondary measures, a clinician-rated severity scale (scored 1–7, lower being better) fell by 1.2 points in the 2 mg group, 1.4 points in the 4 mg group, and 0.8 points in the placebo group. A separate objective test — where participants tried to stay awake in a quiet setting and the time before dozing was measured in minutes (up to 30 minutes; longer is better) — showed average increases of 2.07 minutes (2 mg), 4.25 minutes (4 mg), and 2.73 minutes (placebo). Additional pre-specified scales asked patients and clinicians to rate overall change on a 1–7 scale (where 1 = very much better and 7 = very much worse); patients in the 2 mg group averaged 3.2, the 4 mg group 2.8, and the placebo group 3.7, while clinicians rated the 2 mg group at 2.8, the 4 mg group at 2.6, and the placebo group at 3.5. 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 ↗

  • NCT05687903 · results posted 9 January 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 112 people across five groups to study a drug called TAK-861 in different doses for narcolepsy (a condition causing extreme daytime sleepiness and sudden muscle weakness). The five groups were: a placebo (dummy pill) group of 22 people, and four TAK-861 dose groups of 21–23 people each. The trial ran for 8 weeks and measured how long participants could stay awake during a formal test, how sleepy they felt on a standard questionnaire, how often they experienced cataplexy (sudden episodes of muscle weakness), and how many people experienced any unwanted medical events after starting the study drug. The reported data shows the following at the 8-week mark. For the main outcome — a supervised "stay awake" test measured in minutes — the placebo group's average score changed by −1.16 minutes from the start, while the four TAK-861 dose groups showed changes of +12.49, +23.50, +25.42, and +14.96 minutes respectively. On the sleepiness questionnaire (scored 0–24, where higher means sleepier), the placebo group's score changed by −2.50 points, while the TAK-861 groups changed by −8.92, −13.79, −12.81, and −11.29 points. For weekly cataplexy attacks, the placebo group reported an average of 8.76 attacks per week at week 8, compared with 4.24, 3.14, 2.48, and 5.89 in the four TAK-861 groups. Regarding unwanted medical events after starting the study drug, 7 out of 22 placebo participants experienced at least one such event, compared with 13, 15, 21, and 21 out of roughly 23 participants in the TAK-861 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.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05687916 · results posted 9 January 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT05687916) enrolled 71 people in total, split across three groups: 24 received a placebo (a dummy treatment), 23 received a dose of TAK-861 called "2 mg BID" (meaning twice a day), and 24 received a varying dose of TAK-861 (starting at 2 mg and moving to 5 mg). The trial was measuring how well participants could stay awake, using a standard test called the Maintenance of Wakefulness Test (MWT), which records brain activity to track how long someone can resist falling asleep during 40-minute rest sessions. It also measured how sleepy participants felt during daily life using a self-rated questionnaire called the Epworth Sleepiness Scale (ESS), where higher scores mean greater daytime sleepiness. The reported data shows that, after 8 weeks, the average improvement in the time participants could stay awake (compared to their starting point) was 2.14 minutes for the placebo group, 1.90 minutes for the fixed 2 mg twice-daily group, and 4.54 minutes for the group whose dose was adjusted up to 5 mg. On the sleepiness questionnaire — scored from 0 to 24 — the reported average reduction in score (lower scores meaning less sleepiness) was 3.39 points for the placebo group, 3.71 points for the fixed 2 mg group, and 6.45 points for the dose-adjusted group. The reported data also shows how many participants in each group experienced at least one adverse event (an unintended medical occurrence during the study): 8 out of 24 in the placebo group, 10 out of 23 in the fixed 2 mg group, and 18 out of 24 in the dose-adjusted group. The trial did not report further detail on what those events were within this dataset. 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 ↗

  • NCT04096560 · results posted 29 October 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04096560) tested an investigational oral medicine called TAK-994 at different doses. It was organised into three parts (A, B, and C). In total, 97 people started the trial across all groups. Part A (22 people) focused on early monitoring of how the body responded to the medicine, comparing two doses of TAK-994 (120 mg and 180 mg) against a placebo (a dummy pill with no active ingredient). Parts B and C (90 people across several dose levels) looked at a measure called the Maintenance of Wakefulness Test (MWT) — a standard test where participants sit quietly and try to stay awake, with brain activity recorded to measure how long it takes for sleep to begin (called "sleep latency"). The trial was stopped early, which meant that Part C did not collect the planned follow-up measurements. The reported data shows the following for Part A's safety monitoring: in the group receiving 120 mg of TAK-994, 6 out of 7 participants experienced at least one unexpected medical event after starting the study drug, while in the 180 mg group, 7 out of 8 did; in the placebo group, 2 out of 7 did. For abnormal blood and urine test results, small numbers of participants across groups met pre-set criteria for notable changes. For vital signs (such as blood pressure and heart rate), similar small numbers were recorded across groups. For heart tracing (ECG) readings, again small numbers across groups met the criteria for notable changes. These are counts only — the data does not describe what each event involved in detail beyond the categories listed. For Parts B and C, the reported data shows changes in average sleep latency (how quickly sleep onset was detected) from the start of the study. The placebo group's average changed by minus 2.5 minutes (meaning sleep came slightly faster). The reported figures for the TAK-994 groups showed average increases in sleep latency of 23.9 minutes (30 mg dose), 27.4 minutes (90 mg dose), and 32.6 minutes (180 mg dose). No post-baseline data was reported for the Part C group due to the early stopping of the trial. Additionally, blood concentration measurements from Part A showed that the peak level of TAK-994 detected in the bloodstream was reported as 305.5 ng/mL for the 120 mg dose and 679.1 ng/mL for the 180 mg dose, with some variation also reported across 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.

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

  • NCT04667338 · results posted 4 October 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04667338) enrolled 210 people in Spain who had been diagnosed with narcolepsy — 157 with Narcolepsy Type 1 and 53 with Narcolepsy Type 2. All 210 participants completed the study. The trial was not testing a new medicine; instead, it was an observational study designed to document what treatments people with narcolepsy were already receiving, and to gather information about their personal and health backgrounds. The reported data shows that the vast majority of participants in both groups had received some form of treatment since their diagnosis. Specifically, around 95% of those with Type 1 narcolepsy and approximately 92% of those with Type 2 narcolepsy were reported as having received pharmacological (medication-based) treatment. A much smaller proportion — about 6% of the Type 1 group and roughly 2% of the Type 2 group — were reported as having received non-pharmacological (non-medication) treatments. Among the small number who had never been treated at all (8 people with Type 1 and 4 with Type 2), none were recorded as having used non-pharmacological treatments, while about 6% of the treated group overall had done so. The reported data also shows differences in treatment patterns depending on whether participants attended public or private hospitals, though the specific context behind those percentage figures was not fully detailed in the submitted results. The reported data also includes some background information collected about participants, such as height (an average of about 168.6 cm for the Type 1 group and 171.0 cm for the Type 2 group), as well as numbers relating to gender, lifestyle, and family history — though the full breakdown of those figures was not completely detailed 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT02611687 · results posted 19 September 2024

    According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called pitolisant in people with narcolepsy — a condition that causes extreme daytime sleepiness and, in some cases, sudden muscle weakness (called cataplexy). The trial had two phases: an 8-week phase where 72 people received pitolisant and 38 received a placebo (a dummy treatment with no active ingredient), followed by a longer open-label phase of more than 11 months where everyone received pitolisant. The trial measured changes in daytime sleepiness and narcolepsy symptoms using standard questionnaire-based rating scales. The reported data shows the following score changes over the 8-week double-blind phase. On the Ullanlinna Narcolepsy Scale (a questionnaire scored from 0 to 44, where higher scores mean more severe symptoms), the pitolisant group's scores fell by an average of 6.29 points, compared to a fall of 2.60 points in the placebo group. On the Pediatric Daytime Sleepiness Scale (scored 0 to 32, with scores above 13 considered to reflect abnormal sleepiness), the pitolisant group's scores fell by an average of 5.53 points, compared to 2.11 points in the placebo group. For participants with the type of narcolepsy that includes cataplexy, a specific sub-score of the Ullanlinna scale (ranging from 0 to 16) fell by an average of 2.88 points in the pitolisant group, compared to 1.12 points in the placebo group. In all cases, both groups showed a reduction in scores from their starting point. It is worth noting that the reported data covers score changes only — no other details about participant characteristics or additional outcomes 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.

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

  • NCT04794491 · results posted 9 January 2024

    According to the results reported on ClinicalTrials.gov, 62 people took part in this trial. All participants had already been taking a medication called Xyrem (sodium oxybate) and were switched to a similar medication called XYWAV (low-sodium oxybate). The trial was looking at how this switch affected the number of cataplexy attacks participants experienced each week — cataplexy being a sudden, brief loss of muscle control that can happen in people with narcolepsy. The trial also tracked things like nausea, daytime sleepiness, and how participants felt overall after the switch. Of the 62 who started, 54 completed the trial. The reported data shows that the average change in weekly cataplexy attacks was 0.98 attacks per week (meaning, on average, participants experienced roughly one fewer attack per week compared to their starting point, though the direction of this change should be interpreted alongside the full study report). For nausea — measured on a scale of 0 to 100, where higher means more nausea — the reported average score was 3.13 out of 100. When participants were asked to rate their overall impression of how they had changed (on a 7-point scale from "very much improved" to "very much worse"), the reported data shows 1 person rated themselves as very much improved, 9 as much improved, 12 as minimally improved, 26 as no change, and 3 as minimally worse, with no participants reporting being much worse or very much worse. The reported change in daytime sleepiness scores (Epworth Sleepiness Scale) was -0.6, indicating a small shift on that scale. The reported data also shows that, on average, it took participants about 2.6 days to reach their final, stable dose of XYWAV, and that for most participants (48 out of those assessed), no dose changes were needed after the first dose was set, while 6 participants required one change. 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 ↗

  • NCT04820842 · results posted 26 December 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT04820842) tested different doses of an investigational drug called TAK-994 (at 30 mg, 90 mg, and 180 mg daily) across two phases. In the first phase — an 8-week period where all participants received the active drug — 8, 9, and 9 people started in the three dose groups respectively, though relatively few completed it (5, 1, and 2 people). A smaller number then moved into a second 4-week phase where some continued on TAK-994 and others were switched to a placebo (an inactive dummy treatment) without knowing which they were receiving. The trial's primary focus was on tracking and counting certain medical events and unusual test results that occurred while participants were taking the study drug. The reported data shows that during the 8-week active drug period, 5 out of 8 participants in the 30 mg group, 4 out of 9 in the 90 mg group, and 3 out of 9 in the 180 mg group experienced at least one medical event that occurred after starting the study drug. Regarding unusual laboratory test results, the 30 mg group had none reported, while 1 person in the 90 mg group and 2 people in the 180 mg group had at least one result flagged as markedly outside the normal range. Small numbers of participants across the groups also had unusual readings recorded for vital signs (such as blood pressure or heart rate) and heart tracing (ECG) measurements, with the specific counts varying by dose group and measurement type. The reported data shows that during the shorter 4-week withdrawal phase, very few participants were involved overall (between 1 and 3 per group). Of these, 1 person in the 90 mg TAK-994 group and 1 person in the placebo group experienced at least one medical event after starting that phase, while the 30 mg and 180 mg TAK-994 groups had none recorded. No participants in any group during this phase had laboratory test results flagged as markedly abnormal. 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 ↗

  • NCT03881852 · results posted 24 August 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03881852) enrolled 21 people across two groups — 11 in Sequence 1 and 10 in Sequence 2. It was a crossover study, meaning participants took both the active treatment (AXS-12, also known as reboxetine) and a placebo (an inactive dummy treatment) at different points during the trial. The main thing being measured was the change in the average weekly number of cataplexy attacks (sudden episodes of muscle weakness) from the start of the study. The reported data shows that, on average, participants in the AXS-12 group had a reported change of +13.0 fewer weekly cataplexy attacks compared to their starting point, while those in the placebo group had a reported change of −0.28 (meaning virtually no change, or a very slight increase). These figures are presented as "least squares means," which is a statistical method used to adjust and compare averages across the two groups in a crossover design. It is worth noting that only one outcome measure — the weekly cataplexy attack count — appears to have been reported in the submitted results data; no secondary outcome data was included in the information provided. 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 ↗

  • NCT02720744 · results posted 22 March 2022

    According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called FT218 compared to a placebo (a dummy treatment with no active ingredient) in people with narcolepsy — a condition that causes extreme daytime sleepiness and sudden episodes of muscle weakness called cataplexy. A total of 107 people were assigned to the FT218 group and 105 to the placebo group. Of those, 69 people in the FT218 group and 79 in the placebo group completed the trial. Three things were measured: how well people stayed awake during a standard test, how much their overall daytime sleepiness improved in their doctor's opinion, and how often cataplexy attacks occurred. The reported data shows the following numbers. On the wakefulness test — where participants tried to stay awake in a quiet room and the time before dozing off was recorded — the FT218 group showed an average improvement of 10.8 minutes from their starting point, compared to 4.7 minutes in the placebo group. For the doctor's overall impression of daytime sleepiness improvement, 72% of people in the FT218 group were rated as "much improved" or "very much improved," compared to 31.6% in the placebo group. Regarding cataplexy attacks, the FT218 group reported an average reduction of 11.5 attacks over the measurement period, while the placebo group reported an average reduction of 4.9 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.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02637076 · results posted 23 March 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 2 people with narcolepsy with cataplexy and 15 healthy volunteers (used as a comparison group). Of those, 1 person with narcolepsy and 10 healthy volunteers completed the study. The trial was measuring how a single 3-gram dose of Xyrem (sodium oxybate, a medication used for narcolepsy) affected dopamine activity in the brain, using a type of brain scan called a PET scan. The scans used special tracers — labelled chemicals that attach to specific targets in the brain — to estimate how much dopamine was present at different points in time after taking the dose. The reported data shows the following for the main (primary) measurements: One hour after taking Xyrem, the binding levels of the tracer [C-11]raclopride (a measure of how much it attached to dopamine receptors — higher binding roughly suggests less dopamine occupying those receptors at that moment) were reported as 2.94 for the narcolepsy group and 3.01 for the healthy group. The percentage change from each person's own starting (baseline) level at the one-hour mark was reported as approximately 13% for the narcolepsy group and 6% for the healthy group. At seven hours after the dose, the reported binding levels were lower than baseline for the narcolepsy group (around –8% to –12% change across different brain regions measured), while the healthy group showed little to no change from baseline at that time point (around 0% to –2%). The reported data also shows results for the secondary measurements, which used a different tracer ([C-11]DTBZ) at five hours after the dose. The percentage change from baseline for that tracer was approximately 2% to 7% for the narcolepsy group and around –2% to 2% for the healthy group across the brain regions reported. Because the narcolepsy group was very small (only one person completed the study), these numbers should be understood as extremely preliminary observations rather than conclusions about any broader group 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT02806908 · results posted 13 January 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02806908) enrolled 24 people in total — 11 in one group and 13 in the other — in a crossover design, meaning each participant took both JZP-110 (also known as solriamfetol) and a placebo at different times. Most participants finished the trial (10 and 12 respectively, with one dropout in each group). The trial was measuring how steadily people could keep a car in its lane during a simulated drive — a measure called "Standard Deviation of Lateral Position" (SDLP), which essentially tracks how much a vehicle weaves side to side. A lower SDLP number means less weaving. The reported data shows that the main (primary) outcome was SDLP measured roughly two hours after taking the dose. At that point, the placebo group recorded an average SDLP of 20.46 centimetres, while the JZP-110 group recorded 19.08 centimetres. At the six-hour mark (a secondary outcome), the reported figures were very close — 19.78 centimetres for placebo and 19.59 centimetres for JZP-110. The trial also looked at how many individual participants showed a meaningful change in their driving — either improved (less weaving) or impaired (more weaving) — compared to when they took the placebo. Across several different thresholds of change tested, the reported numbers of participants showing improvement ranged from 5 to 10, and those showing impairment ranged from 4 to 5, depending on which threshold 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.

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

  • NCT03748979 · results posted 8 December 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT03748979) tested a drug called TAK-925 at different doses given by infusion. It was split into several parts (Parts A, B, and C), and in total 57 people took part — all of whom completed the study with no drop-outs reported. The trial was primarily looking at how many participants experienced any unwanted medical events after receiving the drug or a dummy treatment (placebo), and secondarily at how the drug moved through the body (for example, how much of it appeared in the bloodstream) and how it affected people's ability to stay awake during a standard test. The reported data shows that for the primary measure — the number of people who had at least one unwanted medical event after treatment — the counts were generally low across all groups. For example, none of the 6 people receiving the 44 mg dose in Part A reported such an event, while 4 of the 6 people receiving the 180 mg dose in Part A did. In the placebo groups, 1 person (out of 6) in Part A's pooled placebo group and 1 person (out of 4) in Part B's pooled placebo group reported an event, while none of the 5 people in Part C's pooled placebo group did. For the blood concentration measures, the reported data shows that higher doses were associated with higher measured drug levels in the blood at the end of the infusion — for instance, the 44 mg dose groups showed levels around 68–74 nanograms per millilitre, while the 180 mg group showed around 300 nanograms per millilitre. For the wakefulness test (which measures how long it takes a person to fall asleep, where a longer time means greater ability to stay awake), the reported data shows that on Day 7, some TAK-925 groups had larger changes from their starting point compared to placebo — for example, the 11 mg group in Part B showed a reported change of about 35 minutes compared to about −0.7 minutes in the Part B placebo group, and the 112 mg group in Part C showed a reported change of about 31 minutes compared to about 2.6 minutes in the Part C 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 ↗

  • NCT03030599 · results posted 12 November 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT03030599) investigated a treatment called JZP-258 in people with narcolepsy, specifically looking at cataplexy (sudden episodes of muscle weakness) and daytime sleepiness. A total of 201 participants started the trial. The study had several stages: first, everyone received JZP-258 openly while the dose was adjusted, then those who were stable were randomly assigned — without knowing which they received — to either continue on JZP-258 (69 people) or switch to a placebo, meaning a dummy treatment with no active ingredient (67 people). This "randomised withdrawal" design was used to measure what happened when some participants stopped receiving the active treatment. The reported data shows that, for the main outcome being measured — the change in the weekly number of cataplexy attacks — the JZP-258 group had a reported change of 0.00 attacks, while the placebo group had a reported change of 2.35 attacks (meaning those on placebo recorded more attacks over time). For daytime sleepiness, measured using a standard self-reported questionnaire scored from 0 to 24 (where higher scores mean more sleepiness), the reported change was 0.00 for the JZP-258 group and 2.0 for the placebo group. The reported data also shows that when participants and their doctors were asked to rate overall change in the narcolepsy condition, 3 out of 69 participants in the JZP-258 group rated themselves as "much worse" or "very much worse," compared to 29 out of 67 in the placebo group; similarly, doctors rated 4 participants in the JZP-258 group and 39 in the placebo group as "much worse" or "very much worse." Additional secondary outcomes looked at quality of life using standard health surveys (the SF-36v2 and EQ-5D-5L). The reported data shows small numerical differences between the two groups across these measures, though some individual figures within those scales were reported as 0.00, suggesting little to no average change was recorded for certain components in certain groups. Where figures appeared incomplete or repeated in the data, the full breakdown was not clearly reported for every sub-scale. 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 ↗

  • NCT02348593 · results posted 23 July 2019

    According to the results reported on ClinicalTrials.gov, this trial looked at a drug called JZP-110 in three different doses (75 mg, 150 mg, and 300 mg) compared to a placebo (a dummy pill with no active ingredient). A total of 236 people took part, split evenly into four groups of 59. The trial ran for 12 weeks and measured two main things: how long participants could stay awake during a controlled test called the Maintenance of Wakefulness Test (MWT), and how sleepy they rated themselves using a standard questionnaire called the Epworth Sleepiness Scale (ESS), where a higher score means more sleepiness. The reported data shows that on the MWT — where participants try to stay awake in a quiet room and scores range from 0 to 40 minutes, with higher numbers meaning longer time awake — the placebo group's average time awake increased by about 2.1 minutes from the start of the trial to week 12. The reported figures for the JZP-110 groups were increases of 4.7 minutes (75 mg), 9.8 minutes (150 mg), and 12.3 minutes (300 mg). On the ESS questionnaire (scored 0–24, where lower is less sleepy), the reported changes were a reduction of 1.6 points for placebo, and reductions of 3.8, 5.4, and 6.4 points for the 75 mg, 150 mg, and 300 mg groups respectively. The reported data also shows that when participants were asked to rate their own overall change in condition, 39.7% of the placebo group said they felt improved, compared with 67.8%, 78.2%, and 84.7% in the three JZP-110 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.

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

  • NCT02348632 · results posted 25 June 2019

    According to the results reported on ClinicalTrials.gov, this trial involved two stages. First, 643 people took part in an open-label period where everyone received the study drug, JZP-110. Of those, 458 completed this stage. Then, 282 participants moved into a second stage where they were randomly assigned to either continue with JZP-110 (140 people) or switch to a placebo — a dummy treatment with no active ingredient (142 people) — without knowing which they were receiving. The trial was measuring excessive daytime sleepiness, primarily using a questionnaire called the Epworth Sleepiness Scale (ESS), which asks people to rate how likely they are to doze off in eight everyday situations. Scores range from 0 to 24, with higher scores meaning greater sleepiness. The reported data shows that during the two-week randomised stage, the ESS score in the JZP-110 group changed by an average of 1.6 points (indicating slightly more sleepiness compared to the start of that stage), while the placebo group's score changed by an average of 5.3 points (indicating a larger increase in sleepiness). The reported data also shows results from two further questionnaires asking participants and clinicians to rate whether the person's condition felt worse. According to the results reported on ClinicalTrials.gov, 28.2% of people in the JZP-110 group said they felt worse on their own assessment, compared with 64.5% in the placebo group. Similarly, 28.7% of the JZP-110 group were rated as worse by a clinician, compared with 63.8% 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.

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

  • NCT02221869 · results posted 30 April 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02221869) involved children and adolescents with narcolepsy who experience cataplexy — sudden episodes of muscle weakness. A total of 106 participants were enrolled across three groups: 31 were randomly assigned to receive Xyrem (a medicine used for narcolepsy), 32 were randomly assigned to receive a placebo (a dummy treatment with no active ingredient), and 43 took part in an open-label phase where everyone received Xyrem. The main thing the trial was measuring was how the number of weekly cataplexy attacks changed when participants who had been stable on Xyrem were either kept on it or switched to a placebo for a short period. The reported data shows that, for the primary outcome, participants in the Xyrem group had an average change of 0.27 additional cataplexy attacks per week, while those switched to the placebo had an average increase of 12.71 attacks per week. For the secondary outcomes, a clinical rating scale for cataplexy severity (where 0 means no change and +3 means very much improved) showed a score of −0.4 for the Xyrem group and −1.5 for the placebo group, meaning both groups were rated as somewhat worse on average, with the placebo group rated more worse. A daytime sleepiness scale (scored 0–24, where higher means sleepier) showed a change of 0.0 for the Xyrem group and +3.0 for the placebo group. A similar clinical rating for overall narcolepsy showed −0.4 for Xyrem and −1.4 for placebo. For the quality-of-life measure, the reported data shows a change of 0 for the Xyrem group on both physical and psychosocial scores, and 0 and −2.67 respectively 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 ↗

  • NCT02037438 · results posted 4 March 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 920 people in one group (called the "CONV Arm") and 916 people in another group (called the "PCCM Arm") — a total of 1,836 participants. The trial compared two different models of primary care over 12 months, measuring how patients rated their healthcare provider overall, how energetic and vital they felt, how well their provider communicated, and how useful they found their provider's use of technology such as computers and websites during their care. The reported data shows that when participants were asked to rate their provider on a scale of 0 (worst) to 10 (best), the CONV Arm averaged 8.32 and the PCCM Arm averaged 8.45. For the energy and vitality measure — scored on a scale of 0 to 100, where a higher score means less disability — the CONV Arm reported an average of 48.0 and the PCCM Arm reported 47.1. On provider communication (scored 1 to 4, where 4 means "always"), both groups scored closely: 3.59 for CONV and 3.64 for PCCM. For the helpfulness of the provider's use of computers during visits (scored 1 to 3, where 1 is most helpful), both groups again scored similarly at 2.03 and 2.06 respectively. Finally, for the helpfulness of the provider's website in sharing test results and care information (scored 1 to 4), the CONV Arm averaged 3.31 and the PCCM Arm averaged 3.30. It is worth noting that not all participants completed the study — 346 in the CONV Arm and 355 in the PCCM Arm 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.

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

  • NCT01681121 · results posted 11 September 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT01681121) enrolled 93 people in total — 44 received a treatment called ADX-N05 and 49 received a placebo (a dummy treatment with no active ingredient). Of these, 36 in the ADX-N05 group and 38 in the placebo group completed the trial. The study was measuring two main things: how long participants could stay awake during a series of timed tests (called the Maintenance of Wakefulness Test, or MWT), and whether doctors rated participants' overall condition as improved compared to the start of the trial. The reported data shows that, at the final assessment, the ADX-N05 group's average time staying awake in the MWT increased by 12.8 minutes from their starting point, compared to an increase of 2.1 minutes in the placebo group. For the doctor's overall rating of change, 37 out of 44 participants in the ADX-N05 group were rated as at least "minimally improved," compared to 18 out of 49 in the placebo group. The reported data also shows results from a self-reported sleepiness questionnaire (the Epworth Sleepiness Scale, scored 0–24 where lower scores suggest less sleepiness): at four weeks, the ADX-N05 group's score had dropped by an average of 5.6 points from the start, while the placebo group's score dropped by 2.4 points. Additional secondary measurements looked at each of five individual MWT test sessions separately, at both the four-week and final assessment points. The reported data shows that, across all five sessions and both time points, the changes in minutes for the ADX-N05 group were consistently larger than those seen in the placebo group, though the exact figures varied across each session. 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 ↗

  • NCT01006122 · results posted 9 May 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 95 people in total (47 in one group, 48 in the other). It used a "crossover" design, meaning participants took the investigational drug — called PF-03654746 — for one period, then switched to a placebo (a dummy treatment with no active ingredient) for another period, or vice versa, with a washout break of at least seven days in between. The trial was looking at people with narcolepsy, a condition that causes severe daytime sleepiness and sudden muscle weakness (known as cataplexy). By the end of the study, 53 of the original 95 participants had completed both treatment periods. The reported data shows that the primary thing being measured was a test called the Maintenance of Wakefulness Test (MWT), which asked participants to try to stay awake during six 20-minute sessions in a darkened room. Scores could range from 0 to 20 minutes per session. According to the results reported on ClinicalTrials.gov, the average change from the starting score was 6.30 minutes for those on PF-03654746 and 5.81 minutes for those on placebo. Several secondary measures were also tracked. On the Epworth Sleepiness Scale — a self-rated questionnaire scored from 0 to 24 where higher numbers mean more sleepiness — the reported average starting score was around 16.5 in both groups. The reported changes over time ranged from roughly −2.0 to −2.9 for the PF-03654746 group and −0.7 to −1.8 for the placebo group across different time points. For fatigue (measured on a scale of 0–90), cataplexy episode counts, overall health (SF-36 survey), and a clinician-rated improvement scale, the reported data shows relatively small numerical differences between the two groups across the various time points measured; all specific figures are listed 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.

    View reported results on ClinicalTrials.gov ↗

  • NCT00132873 · results posted 25 November 2013

    According to the results reported on ClinicalTrials.gov, this trial involved 59 people who were given a medication called Xyrem (sodium oxybate). Of those 59 participants, 50 completed the trial and 9 did not finish. The trial was measuring two main things over the course of one year: how many participants experienced side effects or unwanted reactions (called "treatment-emergent adverse events"), and what participants' breathing rates were at the end of the year. The reported data shows that 54 out of 59 participants experienced at least one treatment-emergent adverse event — that is, an unwanted reaction that occurred during the time they were taking the medication. Regarding breathing rate, the reported data shows that, on average, participants were taking 14.0 breaths per minute at the one-year mark. No other outcome figures were included in the submitted results data, so no further numbers can be described here. It is worth noting that this trial had only one group — everyone received Xyrem — so there was no comparison group receiving a different treatment or a dummy pill. This means the reported numbers describe what was observed in the Xyrem group only, without a direct comparison. 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 ↗

  • NCT01183312 · results posted 27 March 2013

    According to the results reported on ClinicalTrials.gov, this trial involved 10 people in total, split into two groups of five. It used a "crossover" design, meaning everyone tried both treatments — a sublingual (dissolved under the tongue) form of flumazenil and a placebo (inactive treatment) — with at least a week's break in between. The trial was measuring alertness and reaction speed using a computerised task called the Psychomotor Vigilance Task (PVT), which asks people to press a button as quickly as possible when a visual signal appears on a screen. The reported data shows that for the main outcome — change in median reaction time — both groups showed a slight worsening compared to their starting point rather than an improvement. With placebo, the average change was −9.86 milliseconds, and with flumazenil it was −4.46 milliseconds (a negative number here means reaction times were slightly slower than at the start, not faster). For the secondary measures, the reported data shows similarly small numerical differences between flumazenil and placebo across measures such as the number of very slow responses (lapses), the fastest response times, the number of button presses made when no signal appeared, and participants' own ratings of how sleepy they felt on a 1–10 scale. The numbers across all these measures were close between the two treatments, and no data was missing from the reported results. It is worth noting that with only 10 participants, this was a very small study, and the reported results on ClinicalTrials.gov reflect that limited scale. 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 ↗

  • NCT00066170 · results posted 30 November 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 231 people in total across four groups. Participants were people with narcolepsy (a condition causing excessive daytime sleepiness) who were randomly assigned to receive either: a placebo (dummy treatment) for both medications; Xyrem (sodium oxybate) with a placebo for the other medication; modafinil at their usual established dose with a placebo for the other medication; or both Xyrem and modafinil together. The trial was measuring how well participants could stay awake during the daytime, tested over 8 weeks. The reported data shows that the main outcome was measured using something called the Maintenance of Wakefulness Test (MWT) — a series of four short tests where participants sit in a quiet, dimly lit room and try to stay awake, with researchers recording how many minutes pass before they fall asleep. The trial looked at how much this score changed from the start of the study to week 8. According to the results reported on ClinicalTrials.gov, the group receiving both placebos saw their score go down by 2.72 minutes (meaning they fell asleep faster). The group on Xyrem alone saw a small increase of 0.58 minutes, the modafinil-only group saw a slight decrease of 0.53 minutes, and the group taking both Xyrem and modafinil together saw an increase of 2.68 minutes — meaning they took longer to fall asleep compared to when the study started. No secondary outcome data was 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.

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

  • NCT00228553 · results posted 31 March 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 743 people who were taking armodafinil (at doses of 100 to 250 mg per day) for one of three sleep-related conditions: narcolepsy (a condition causing sudden, uncontrollable sleepiness), obstructive sleep apnoea/hypopnoea syndrome (where breathing repeatedly stops during sleep), or shift work sleep disorder (disrupted sleep caused by working non-standard hours). The trial ran for up to two years and had a single group — there was no comparison or placebo group reported. Of the 743 people who started, 313 completed the trial and 430 did not complete it. The reported data shows that the primary outcome the trial was measuring was safety and tolerability — in other words, what unwanted medical events (called "adverse events") occurred in participants over time. Researchers tracked both serious adverse events (those leading to outcomes such as death, hospitalisation, or significant disability) and non-serious adverse events. According to the results reported on ClinicalTrials.gov, 667 out of the 743 participants experienced at least one adverse event of any kind. The data as submitted does not provide a further breakdown of how many of these were serious versus non-serious, so those figures cannot be described here. It is worth noting that no secondary outcome measure data appears to have been included in the submitted results. The reported data shows only the single primary safety measure described above. 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 ↗

  • NCT00078312 · results posted 22 February 2010

    According to the results reported on ClinicalTrials.gov, this trial involved 328 people who all received armodafinil (at doses ranging from 100 to 250 mg per day). There was only one group in this study — meaning everyone received the same treatment, with no comparison or placebo group. The trial was measuring the safety and tolerability of armodafinil by tracking how many participants experienced adverse events (that is, unwanted or unexpected medical occurrences during the study). Of the 328 people who started, 151 completed the study and 177 did not complete it. The reported data shows that the primary outcome measure was the number of participants who experienced adverse events, which were divided into two categories: serious adverse events (those leading to outcomes such as death, hospitalisation, life-threatening situations, lasting disability, or other significant medical events) and non-serious adverse events (anything that did not meet those more serious criteria). According to the results reported on ClinicalTrials.gov, 323 out of 328 participants experienced at least one adverse event of either type. The data does not provide a further breakdown of how many of those events were classified as serious versus non-serious, nor does it report any secondary outcome measures — that information was not 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.

    View reported results on ClinicalTrials.gov ↗

See the full Narcolepsy page · What changed recently

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.