Reported trial results for Restless Legs Syndrome

46 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

• NCT04141891 · results posted 21 February 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 529 older drivers and their "support persons" (such as a family member or friend) at the start — 267 in one group and 262 in the other. Participants were randomly assigned to one of two online resources about driving decisions for older adults: a general "Older Drivers Website" or a more structured tool called a "Driving Decision Aid." The trial tracked people over two years, checking in at 6, 12, 18, and 24 months. The main thing it set out to measure was how uncertain people felt about making decisions related to their driving — a concept called "decisional conflict" — right after they used whichever resource they were given. The reported data shows that immediately after using the resources, the Older Drivers Website group scored 15.2 out of 100 on the decisional conflict scale, while the Driving Decision Aid group scored 12.3 out of 100 — where a lower number means less uncertainty about decision-making. On a related measure of how clearly people understood their own values around the decision, the website group scored 13.8 and the decision aid group scored 12.8 (again, lower is considered better on this scale). For a short knowledge quiz about older adult driving safety, the website group answered 79.9% of questions correctly compared to 88.9% in the decision aid group. Scores for confidence in making decisions (called "decision self-efficacy") were similar between groups — 92.9 for the website group and 93.2 for the decision aid group, on a scale where higher means more confident. The reported data also shows changes over time in two further measures. For depression (measured on a standardised scale where a positive change score means an increase in depression), the website group's scores rose by 0.56, 1.32, 1.46, and 1.20 points at the 6-, 12-, 18-, and 24-month check-ins respectively, while the decision aid group's scores changed by 0.04, 0.26, −1.10, and 0.65 points at those same time points. For decision regret (how much people regretted their decisions over time, where a positive change score means more regret compared to the 6-month mark), the website group's scores changed by +3.24, +2.39, and +1.71 at the 12-, 18-, and 24-month points, while the decision aid group's scores changed by −1.98, −1.57, and +0.37 at those same time 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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• NCT04698343 · results posted 19 September 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04698343) enrolled 20 people who were taking opioid medicines to manage Restless Legs Syndrome (RLS) — a condition that causes uncomfortable sensations and an urge to move the legs. All participants used a non-invasive peripheral nerve stimulation (NPNS) device, which delivers gentle electrical impulses to nerves through the skin. The trial was designed to see whether people could reduce their opioid dose while using the device, and to track any changes in their RLS symptoms across up to three phases of dose reduction. Of the 20 who started, 14 completed the first phase, 4 completed the second phase, and only 3 completed the full study. The reported data shows that when participants reduced their opioid dose by at least 20% in the first phase, 14 out of 14 who reached that stage did not experience what the trial defined as a clinically significant worsening of RLS symptoms — meaning their doctor-rated symptom score did not reach the "much worse" or "very much worse" level on a standard seven-point scale. When the dose reduction was increased to at least one-third, 8 out of the participants at that stage did not show a clinically significant worsening. On a self-rated RLS severity questionnaire (scored 0–40, where higher numbers mean more severe symptoms), the reported average change from the starting score was an increase of 5.8 points during the first dose-reduction phase and 5.7 points during the second. The reported data also shows that the maximum average opioid dose reduction achieved without a clinically significant symptom worsening was approximately 29.9%. Regarding tolerability of the device itself, the reported data shows that 0 participants withdrew from the study specifically because they could not tolerate the NPNS device. It is worth noting that only 3 of the original 20 participants completed all phases of the trial, which means the numbers for later phases are based on very few people. The reasons why 17 participants did not complete the study were not detailed in the data provided here, and some figures that might be expected — such as results for the 3 who completed the final phase — were not reported in the structured 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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• NCT04874155 · results posted 19 September 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04874155) enrolled 133 people in total — 68 in the TOMAC group and 65 in a sham (inactive/pretend treatment) control group. The trial was studying a device called TOMAC for restless legs syndrome (RLS). It measured how participants and their clinicians rated overall improvement, as well as changes in RLS symptom severity and sleep quality, comparing the TOMAC device against the sham control. The reported data shows that for the main outcome — the number of people whose clinician rated them as "Much Improved" or "Very Much Improved" — 29 out of 68 participants in the TOMAC group reached this rating, compared with 10 out of 65 in the sham group. When participants rated themselves using the same type of scale, 33 in the TOMAC group and 12 in the sham group reported being "Much Improved" or "Very Much Improved." On a symptom severity questionnaire scored from 0 to 40 (where higher means more severe), the TOMAC group's average score decreased by 7.2 points from the start of the trial, while the sham group's average decreased by 3.8 points. For sleep quality (scored 0–100, where higher means worse sleep problems), the TOMAC group reported an average decrease of 13.7 points on one sleep scale and 11.8 points on another, compared with decreases of 4.0 and 2.8 points respectively in the sham group. On the clinician-rated overall improvement scale (1 = very much improved, 7 = very much worse), the TOMAC group averaged a score of 2.6 and the sham group averaged 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.

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• NCT04610827 · results posted 22 May 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04610827) looked at three different dosing schedules for an iron supplement called ferrous sulfate — taken once a day, twice a day, or every other day. The trial enrolled a total of 6 participants across the three groups (1, 2, and 3 people respectively). The study was measuring iron levels in the blood (using a marker called ferritin, which reflects how much iron the body has stored) and how many participants experienced side effects such as changes in stool colour, nausea, constipation, or teeth staining. The reported data shows that ferritin levels (measured in micrograms per litre) were recorded for two of the three groups at the end of the study: the twice-daily group had a reported ferritin level of 24 mcg/L, and the every-other-day group had a reported ferritin level of 19 mcg/L. Ferritin data for the once-daily group was not reported in the submitted results. Regarding side effects, the reported data shows that 1 participant in the once-daily group and 1 participant in the twice-daily group experienced side effects, while 0 participants in the every-other-day group did. It is worth noting that this trial was very small — only 6 people were enrolled in total, and not all of them completed the study (1 participant in the once-daily group and 1 in the twice-daily group did not finish). Because of the very small numbers involved, the reported figures should be interpreted with a great deal of caution. 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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• NCT04706091 · results posted 16 January 2024

  According to the results reported on ClinicalTrials.gov, this trial involved 34 people split into two groups in a "crossover" design — meaning each person tried both the active treatment and a placebo (a dummy treatment with no active ingredient) at different times. One group of 18 started on the treatment and then switched to placebo, while the other group of 16 started on placebo and then switched to treatment. The trial was measuring changes in sleep, specifically how long people slept in total, how much time they spent awake after first falling asleep, and how severe their insomnia felt using a standard questionnaire called the Insomnia Severity Index (ISI), which is scored from 0 to 28 (higher scores mean worse insomnia). The reported data shows the following changes in total sleep time (measured by a wrist-worn activity monitor): in the group that received treatment first, total sleep time changed by an average of about 5 minutes during the treatment phase and about 7.6 minutes during the placebo phase. In the group that received placebo first, total sleep time changed by about 11.4 minutes during the placebo phase and about 18 minutes during the treatment phase. For time spent awake after first falling asleep, the reported changes were small — ranging from a reduction of about 1.2 minutes to a small increase of about 0.9 minutes across the different groups and phases. For the insomnia questionnaire, the reported data shows score reductions (meaning less severe insomnia) ranging from about 1.25 points to about 5.69 points across the different groups and phases. It is worth noting that this was a crossover trial, so interpreting which changes are linked to treatment versus placebo requires careful comparison between phases — something that goes beyond simply reading the numbers above. The data as submitted does not include a head-to-head comparison figure, so that information was not reported in the structured results 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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• NCT03992196 · results posted 30 October 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03992196) looked at rotigotine, a skin patch used in people with Restless Legs Syndrome (RLS). A total of 10 people were enrolled across three groups: 1 person in a "no treatment" group (who did not proceed past enrolment), 2 people who received a rotigotine patch at a final dose of 2 mg per 24 hours, and 7 people who received a patch at a final dose of 3 mg per 24 hours. The trial's main focus was on tracking unwanted medical events (called adverse events) that occurred during or shortly after the treatment period, as well as several measures of RLS symptom severity. The reported data shows that, among those who received treatment, 100% of participants in the 2 mg group and approximately 86% (6 out of 7) of participants in the 3 mg group experienced at least one treatment-emergent adverse event — meaning an unwanted medical occurrence that appeared or got worse during or just after the treatment period. Importantly, the reported data shows that 0% of participants in either group stopped taking the study medication because of an adverse event. For all of the secondary outcome measures — which included standardised questionnaire scores rating RLS symptom severity, overall illness severity, and sleep quality — the data was not reported, so no numbers are available for those results. It is worth noting that this was a very small trial with only 9 people receiving treatment, which means the numbers above reflect a very limited group and should be understood in that context. 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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• NCT03539081 · results posted 21 September 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people in total across three groups: 5 people with Restless Legs Syndrome (RLS), 10 people without RLS, and a third group for continuous blood pressure monitoring that had no participants enrolled. Of those who started, 2 people in the RLS group and 7 people in the non-RLS group completed the study. The trial was measuring how spinal cord stimulation — a procedure where mild electrical signals are delivered to the spine — affected nerve activity controlling blood vessels and blood flow in the leg, in people being treated for chronic back pain. The reported data shows two main things were measured. The first was the change in a type of nerve signal activity (called MSNA burst frequency — essentially how often the nerves that control blood vessel tension were firing) from the start of stimulation to 60 minutes in. According to the results reported on ClinicalTrials.gov, this activity decreased by 29% in the RLS group and by 24% in the non-RLS group. The second measure was the change in blood flow through the femoral artery (a large artery in the thigh), measured using an ultrasound technique. The reported data shows this increased by 24% in the RLS group and by 22% in the non-RLS group. No measurements were reported for the continuous blood pressure monitoring 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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• NCT02826681 · results posted 14 September 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 70 people in total — 35 who received an iron infusion called Injectafer (ferric carboxymaltose) and 35 who received a saltwater (normal saline) infusion as a placebo (an inactive comparison treatment). The trial was measuring changes in restless legs syndrome symptom severity, using a standard rating tool called the International Restless Legs Syndrome Severity Scale (IRLSS), from the start of the trial to Day 42. It is worth noting that a relatively large number of participants did not complete the study — 23 in the Injectafer group and 22 in the normal saline group did not finish, leaving 12 and 13 completers respectively. The reported data shows that the primary outcome — the change in IRLSS symptom scores between the two groups — was measured in 12 participants from the Injectafer group and 12 participants from the normal saline group. However, the actual score values or the size of any change in symptoms were not reported in the structured results data submitted to ClinicalTrials.gov, so it is not possible to describe what those numbers showed. No further secondary outcome data appears to have been reported in the submitted results. Because so many participants left the study before it finished, and because the key numbers behind the main outcome were not reported, the available results are quite limited in what they can tell us. 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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• NCT02642315 · results posted 24 February 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02642315) enrolled 10 participants in a single open-label group, meaning everyone received the same treatment and knew they were receiving it. Eight participants completed the study, while two did not finish. The trial was measuring changes in something called "augmentation severity" — a side effect that can develop in people treated for restless legs syndrome, where symptoms can worsen or spread over time. Augmentation severity was rated on a scale from 0 to 24, where 0 represents the least severe and 24 the most severe. The reported data shows that the primary outcome measured the change in augmentation severity scores between the start of the study (Day 0) and Day 90. At the start, the reported average score was 6.5 out of 24, and by Day 90 the reported score was 0. A secondary outcome looked at the same scale but compared Day 0 to Day 360 — which was approximately 270 days after participants had reduced or stopped a type of medication. The reported data shows the same figures: a starting score of 6.5 dropping to 0 by Day 360. It is worth noting that no further breakdown of individual results or variation between participants was 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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• NCT02397057 · results posted 12 October 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 209 people with restless legs syndrome (RLS) — 105 received an iron infusion called Injectafer (ferric carboxymaltose) and 104 received a saltwater (normal saline) infusion as a comparison. By the end of the study, 94 people in the Injectafer group and 91 in the saline group had completed the trial. The trial was measuring changes in RLS symptom severity, how doctors and patients rated overall improvement, and several quality-of-life and sleep measures over 42 days. The reported data shows that on the main RLS symptom scale (scored 15–40, where higher means more severe), both groups started with similar scores — around 24. By day 42, the Injectafer group's average score had dropped by 8.7 points (to about 15.6), while the saline group's average score had dropped by 5.9 points (to about 18.7). On a separate measure where doctors rated patients as "much" or "very much" improved, 38 out of 105 participants in the Injectafer group and 25 out of 104 in the saline group were counted as responders. For the quality-of-life questionnaire (where lower scores mean better quality of life), both groups started around 54–56 and both showed a small improvement of roughly 9 points by day 42. On the fatigue scale, the reported change from baseline was a reduction of about 10 points in the Injectafer group and about 16.5 points in the saline group. On the sleep disturbance scale, the Injectafer group showed a reported reduction of about 13 points and the saline group about 9 points; no further breakdown of the sleep scale data was 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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• NCT02526277 · results posted 18 February 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 28 people in total, split across four groups: one group used an MMF07 Foot Massager Device (8 people), one used heat therapy (6 people), one used both the massager and heat therapy together (7 people), and one received no treatment (7 people). All 28 participants completed the trial. The study was measuring symptoms of Restless Legs Syndrome (RLS) — an uncomfortable urge to move the legs — along with quality of life and sleep, using three different questionnaires completed by participants. The reported data shows the following scores on the primary measure, the International Restless Legs Severity Scale, where higher numbers (out of 40) mean more severe symptoms: the no-treatment group scored 21.3, the heat therapy group scored 17.3, the combined massager and heat therapy group scored 16.9, and the massager-only group scored 12.3. For the quality-of-life questionnaire (where higher scores, up to 100, indicate better quality of life), the reported data shows the massager-only group scored 82.4, the combined group scored 74.2, the heat therapy group scored 66.7, and the no-treatment group scored 57.1. For the sleep scale (where higher scores, up to 100, indicate better sleep), the no-treatment group scored 48.6, the combined group scored 37.0, the heat therapy group scored 31.2, and the massager-only group scored 26.6. It is worth noting that this was a small trial with between 6 and 8 people in each group, so the reported numbers should be understood in that context. The trial measured and recorded these scores, but no conclusions about what the numbers mean for any individual should be drawn from this summary 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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• NCT03249779 · results posted 4 September 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT03249779) enrolled 8 participants, all of whom completed the study with no drop-outs. The trial used a device called a "Scrambler" — a type of nerve stimulation device — and was measuring its effect on restless legs syndrome. To track any changes, participants filled out a standard questionnaire called the International Restless Legs Syndrome Rating Scale (IRLS), which asks 10 questions about symptoms such as how often and how severely they occur. Scores on this scale range from 0 to 40, where lower numbers mean fewer or less bothersome symptoms and higher numbers mean more or worse symptoms. The reported data shows two separate IRLS score measurements recorded for the group. One reported score was 20.25 and the other was 19.5, both out of a possible 40. These appear to represent scores measured at different points during the study (for example, before and after treatment), though the data as submitted does not clearly label which score belongs to which time point. The difference between the two figures — roughly 0.75 points on the 0–40 scale — is what was captured as the change. No further breakdown of individual participant scores or additional outcome details were reported in the submitted data. It is worth noting that this was a very small study of only 8 people and involved just one group, meaning there was no comparison group receiving a different treatment or a dummy (placebo) device. Because of this, the reported numbers on their own have important limitations in terms of what conclusions can be drawn from them. 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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• NCT03053427 · results posted 10 July 2019

  According to the results reported on ClinicalTrials.gov, this trial looked at a medication called gabapentin enacarbil compared to a placebo (a dummy pill with no active ingredient) in people with Restless Legs Syndrome (RLS). A total of 375 people took part — 186 in the placebo group and 189 in the gabapentin enacarbil group. The main thing the trial was measuring was how much participants' RLS symptom scores changed over 12 weeks, using a standard 10-question rating scale called the IRLS, where higher scores mean more severe symptoms and the maximum possible score is 40. The reported data shows that, at the 12-week mark, both groups had lower (improved) symptom scores compared to where they started. The placebo group's score dropped by an average of 10.5 points, while the gabapentin enacarbil group's score dropped by an average of 11.7 points. For the secondary outcomes, the reported data shows that around 53% of the placebo group and 57% of the gabapentin enacarbil group were rated by their doctor as "much improved" or "very much improved." Similarly, about 51% of placebo participants and 56% of gabapentin enacarbil participants rated themselves in those same categories. Two separate sleep quality scales were also measured; the reported data shows that both groups had identical average improvements on both scales, with no reported difference between them. 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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• NCT00256854 · results posted 15 March 2019

  According to the results reported on ClinicalTrials.gov, this trial looked at what happens when people taking a short-acting form of a medication called ropinirole (used for Restless Legs Syndrome, or RLS) are switched to a longer-acting form of the same medication. A total of 135 people started the trial across six groups, with each group receiving a different dose level. The groups were given the medication in a set sequence that included both the switch to the longer-acting version and a comparison switch within the same short-acting form. Most participants completed the study — between 13 and 24 people finished in each group, with a small number not completing. The main thing the trial measured was how many participants experienced any unfavourable health changes (called adverse events, or AEs — meaning any unwanted change in health noticed during the study, whether or not it was caused by the medication) after switching between formulations. The reported data shows that across the six groups, the number of participants who experienced at least one adverse event ranged from 5 to 14 people per group in the first conversion period, and from 5 to 8 people per group in the second conversion period. For one of the secondary measures — participants who stopped taking the drug due to an adverse event — the reported data shows this occurred in only 1 participant each in two of the six groups, and zero in all others. The reported data also shows that no serious adverse events (those involving hospitalisation, life-threatening situations, or lasting harm) were recorded after either conversion, across all six groups. For the other secondary measures, the reported data shows that on a standard RLS symptom severity scale (scored 0–40, where higher means worse), most groups showed small reductions in their scores one week after switching, ranging from a decrease of 5.8 points to a small increase of 1.2 points depending on the group and conversion period. On a separate global improvement scale rated by clinicians, the reported data shows that between 5 and 14 participants per group per conversion period were recorded as showing a positive response (meaning their condition was rated as stable or improved compared to baseline). A small number of participants also had blood pressure readings considered outside normal ranges at certain time points, though the reported data for this measure was limited in detail. 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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• NCT01498120 · results posted 21 September 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 14 participants, all of whom received a treatment called rotigotine. The trial was looking at unwanted medical events (called adverse events) that participants experienced during the study — specifically, how many people had at least one such event, and how many had to stop taking the treatment because of one. Only 1 participant completed the study, while 13 did not complete it. The reported data shows that out of the 14 participants, 10 experienced at least one adverse event during the study period. An adverse event, as defined in this trial, is any unwanted medical occurrence that happened while a person was taking the study treatment, regardless of whether it was actually caused by that treatment. Additionally, 3 participants withdrew from the trial specifically because of an adverse event. The trial does not appear to have reported any other outcome measures beyond these two. It is worth noting that this was a very small study, and the data as submitted does not include results on whether the treatment achieved any particular health benefit — only these counts of unwanted medical events 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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• NCT01931878 · results posted 21 March 2016

  According to the results reported on ClinicalTrials.gov, this trial involved 24 people with restless legs syndrome. It used a "crossover" design, meaning participants were split into two groups — one group received a placebo (an inactive injection) first and then switched to the active treatment (incobotulinumtoxin A, also known as Xeomin), while the other group received the active treatment first and then switched to the placebo after three months. The trial was measuring symptom severity, pain levels, and how participants felt their condition had changed overall. The reported data shows that on a restless legs symptom scale scored from 1 to 40 (where higher numbers mean more severe symptoms), the average score during the placebo period was 25.19, compared to 19.46 during the Xeomin treatment period. For pain, participants rated their discomfort on a scale of 0 to 10, and the reported data shows that 3 out of the relevant participants scored below 4 (indicating lower pain) while on the placebo, compared to 12 participants while on Xeomin. For the third measure — a 7-point scale where participants described how much their condition had changed — 3 participants in the placebo group reported feeling "moderately better" or more (a score of 5 or above), compared to 9 participants in the Xeomin group, as reported six weeks after 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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• NCT01988129 · results posted 29 July 2015

  According to the results reported on ClinicalTrials.gov, this trial involved 601 firefighters in an intervention group and 588 in a control group, for a total of 1,189 participants. The trial was measuring whether a health and sleep education programme made a difference to firefighters' sick days, on-the-job injuries, and motor vehicle crashes over 12 months. Some secondary measures looked at changes in total sleep time and alertness (such as nodding off during meetings or on the phone) among those in the intervention group who completed follow-up surveys. The reported data shows that for sick days recorded as "sick time," the intervention group averaged 3.1 days per firefighter over the year, compared with 3.2 days in the control group. For sick days recorded as injury and disability, the intervention group averaged 1.4 days per firefighter, compared with 2.6 days in the control group. For motor vehicle crashes, the reported figures were 0.11 incidents per firefighter in the intervention group and 0.10 in the control group. For on-the-job injuries, the intervention group reported 0.37 injury reports per firefighter and the control group reported 0.40. On the secondary measures — which were only tracked within the intervention group and not compared to a control — average weekly sleep time was reported as 44.84 hours at the start of the study and 45.98 hours at the 12-month follow-up. Incidents of dozing off during meetings were reported at 0.41 per month at the start and 0.30 per month at follow-up, and incidents of falling asleep on the telephone went from 0.06 to 0.05 per month. 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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• NCT01495793 · results posted 14 July 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants, all of whom received a medication called rotigotine, delivered via a skin patch. Twenty-two participants completed the trial, and two did not finish. The trial was a pharmacokinetic study — meaning it was designed to measure how the body processes and moves the medication through the system, not to test whether the medication relieved any symptoms. Specifically, it looked at how quickly the body clears the drug from the bloodstream, and how widely the drug spreads through the body, at four different patch sizes (delivering 0.5 mg, 1 mg, 2 mg, and 3 mg of rotigotine over 24 hours). The reported data shows the following measurements for how quickly the body cleared the unconjugated (unmodified) form of rotigotine from the blood: at the 0.5 mg/24h dose, the clearance rate was reported as approximately 677 litres per hour; at 1 mg/24h, approximately 672 litres per hour; at 2 mg/24h, approximately 938 litres per hour; and at 3 mg/24h, approximately 1,089 litres per hour. These figures simply describe the rate at which the body removed the drug — a higher number means the drug was cleared more quickly at that dose. The reported data also shows how widely the drug distributed through the body at the two lower doses: at 0.5 mg/24h, this was reported as approximately 5,403 litres, and at 1 mg/24h, approximately 6,221 litres. The distribution figures for the 2 mg and 3 mg doses were not reported in the submitted data. It is worth noting that these are measurements of how the body handled the drug, not measurements of any health outcome or symptom change. No secondary outcome data appears to have been submitted to ClinicalTrials.gov for this trial. 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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• NCT00895232 · results posted 10 June 2015

  According to the results reported on ClinicalTrials.gov, this trial looked at a medication called Venofer (an iron infusion given into a vein) as a treatment for Restless Legs Syndrome (RLS). A total of 21 people started the trial, split across three groups: 7 people received one dose of 500mg, 6 people received two doses of 500mg (Cohort II), and 8 people received two doses of 500mg (Cohort III). Not all participants finished the trial — only 4, 2, and 3 people completed it in each group respectively. The trial measured changes in RLS symptom severity using a recognised rating scale (scored from 1, meaning mild, to 40, meaning severe), as well as measuring leg movement activity during sleep. The reported data shows that, by day 84, the average symptom score on the RLS rating scale changed by −2.4 points in the single-dose group, −14.3 points in Cohort II, and −16.0 points in Cohort III — meaning all three groups reported lower (less severe) scores on average compared to where they started, with the two-dose groups showing larger reductions. For leg movements during sleep, the reported average changes were −7.2 movements per hour in Cohort I, −75.0 in Cohort II, and −96.2 in Cohort III. A separate assessment by the examining clinician — rating whether any change was noticed — found that 28.6% of participants in Cohort I, and 66.7% in each of the two-dose groups, were recorded as showing some response of any level. It is worth noting that this was a very small trial and a substantial number of participants did not complete it, which the reported data acknowledges but does not fully explain. 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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• NCT01537042 · results posted 3 November 2014

  According to the results reported on ClinicalTrials.gov, this trial looked at a medication called rotigotine (delivered as a patch) compared to a placebo (an inactive patch) in people with Restless Legs Syndrome (RLS). A total of 30 people started the trial — 10 in the placebo group and 20 in the rotigotine group. All 10 placebo participants finished the trial, while 15 of the 20 rotigotine participants completed it (5 did not finish). The main thing the trial was measuring was the change in something called the Periodic Limb Movement Index (PLMI) — essentially a count of involuntary leg movements per hour while in bed, recorded during a sleep study. The reported data shows that for the primary measure, the PLMI ratio (comparing leg movement counts at the end of the trial to those at the start — where a number below 1.0 means fewer movements than at the start) was 1.16 in the placebo group and 0.51 in the rotigotine group. For a secondary measure looking at the raw change in leg movements per hour, the placebo group showed an increase of 10.3 movements per hour, while the rotigotine group showed a decrease of 23.7 movements per hour. The reported data also shows scores from a standard RLS symptom questionnaire (rated 0–40, where lower is better): the placebo group's score decreased by 8.6 points from their starting score, while the rotigotine group's score decreased by 15.9 points. Two scales measuring sleep satisfaction and RLS severity at night also showed reductions from starting scores in both groups, with the rotigotine group reporting larger reductions than the placebo group on both 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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• NCT01569464 · results posted 26 August 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01569464) looked at rotigotine — a patch-based medicine — compared to a placebo (an inactive patch) in people with Restless Legs Syndrome (RLS). A total of 150 people started the trial: 101 received rotigotine and 49 received the placebo. Of those, 91 in the rotigotine group and 44 in the placebo group completed the study. The trial measured two main things: changes in a standard RLS symptom questionnaire score (called the IRLS, rated from 0 to 40, where higher means worse symptoms), and changes in how uncomfortable participants felt during a sit-still test designed to bring on RLS sensations (rated 0 to 10). The reported data shows that both groups saw their IRLS symptom scores go down over the course of the trial. The rotigotine group's score dropped by an average of about 15.5 points, while the placebo group's score dropped by about 15.2 points. For the sit-still discomfort test, the rotigotine group's score fell by an average of 2.83 points and the placebo group's by 2.90 points. The reported data also shows results for several secondary measures — including leg movement counts during the sit-still test, sleep satisfaction, and RLS severity at bedtime and during the night — where both groups again showed reductions from their starting scores, with the numbers for rotigotine and placebo appearing broadly similar across 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.

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• NCT02085720 · results posted 21 August 2014

  According to the results reported on ClinicalTrials.gov, this study enrolled 819 older Chinese adults, all of whom completed the study with no dropouts. The trial was measuring how common obstructive sleep apnoea syndrome (OSAS) — a condition where breathing repeatedly stops and starts during sleep — is among this group. It also looked at how common restless leg syndrome was, and how long participants who were given a CPAP breathing machine (a device worn during sleep to keep the airway open) actually used it each night. The reported data shows that 15% of the 819 participants were found to meet the criteria for OSAS, based on a home sleep test that counts the number of breathing interruptions per hour. For restless leg syndrome — a condition causing uncomfortable urges to move the legs, particularly at night — the reported figure was 13.8% of participants. Among those who were given a CPAP machine to use at home, the reported average nightly use was 4.2 hours. The data also included a breakdown of sleep-breathing severity results and questionnaire responses, though the specific labels for each individual figure within those categories were not reported in the submitted data, so those numbers cannot be described in full detail 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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• NCT01084551 · results posted 5 June 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01084551) enrolled 284 adults with restless legs syndrome (RLS) — a condition that causes uncomfortable sensations in the legs and an urge to move them. Participants were divided into three groups: 95 received a placebo (a dummy treatment with no active ingredient), 95 received a lower dose of the study medicine called SPM 962 (4.5 mg), and 94 received a higher dose (6.75 mg). The main thing being measured was how much participants' RLS symptoms changed on a standard rating scale called the IRLS, which runs from 0 (no symptoms) to 40 (very severe). A lower score means fewer symptoms. The reported data shows that, by the end of the treatment period, all three groups had lower IRLS scores than when they started. The placebo group's score dropped by an average of 11.6 points, while the two SPM 962 groups dropped by 14.3 and 14.6 points respectively. For the secondary measures, a sleep quality scale (scored 0–21, where lower is better) showed average drops of 2.5 points in the placebo group, 3.1 in the lower-dose group, and 3.2 in the higher-dose group. Clinicians rated participants as "very much improved" or "much improved" for 24.2%, 25.8%, and 29.0% of participants in each group respectively, while larger proportions — 33.7%, 41.9%, and 45.2% — were rated as at least "minimally improved." Participants' own ratings of feeling "very much better" or "much better" were reported for 23.2%, 24.7%, and 30.1% in each group, and at least "a little better" for 38.9%, 48.4%, and 50.5%. The reported data also shows that the percentage of days with RLS symptoms dropped from around 85% at baseline to 48.7% in the placebo group, 35.8% in the lower-dose group, and 36.8% in the higher-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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• NCT00666965 · results posted 25 April 2014

  According to the results reported on ClinicalTrials.gov, this trial looked at a medication given at three different daily doses (2.25 mg, 4.5 mg, and 6.75 mg) compared to a placebo (a dummy treatment with no active ingredient) in people with restless legs syndrome. A total of 230 people took part — roughly 57–58 in each of the four groups. The main thing being measured was how much participants' restless legs syndrome symptoms changed over the course of the treatment period, using a standard 40-point symptom rating scale called the IRLS, where a lower score means fewer or less bothersome symptoms. The reported data shows that all four groups — including the placebo group — had lower IRLS scores by the end of the study, meaning their reported symptom scores went down from where they started. The placebo group's average score dropped by 9.8 points, the 2.25 mg group dropped by 10.7 points, the 4.5 mg group dropped by 14.4 points, and the 6.75 mg group dropped by 14.1 points. On a secondary measure where a clinician rated how ill participants appeared, between 74% and 93% of participants across all groups were rated as showing some level of illness at the end of the study — the full breakdown across severity categories was not clearly separated in the available data. On a separate self-rated scale asking participants how much they felt they had improved, 55% of the placebo group, 70% of the 2.25 mg group, 82% of the 4.5 mg group, and 85% of the 6.75 mg group reported feeling "much" or "very much" improved. Sleep quality and general health status were also measured; the reported changes across groups were relatively modest, though the exact meaning of those figures across all sub-categories was not fully detailed 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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• NCT01562743 · results posted 23 April 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 185 people, all of whom received a treatment called SPM 962 (a single study group with no comparison group). The trial was looking at the long-term use of SPM 962 in people with restless legs syndrome (RLS). The main things being measured were: how often and how seriously unwanted health events (called adverse events) occurred; whether participants experienced a worsening pattern called "augmentation" (where RLS symptoms broaden or intensify over time with dopamine-based treatment); and how sleep quality changed. By the end of the study, 133 of the 185 participants had completed it, while 52 did not finish. The reported data shows that out of 175 participants assessed for adverse events, 139 experienced at least one adverse event of any kind. For specific events of special interest: 29 participants reported sudden onset of sleep, 5 reported obsessive-compulsive or impulse-control disorder, and 1 reported hallucination or delusion. Regarding augmentation, 11 participants were reported to have experienced it, of whom 5 were considered clinically significant cases. For sleep quality (measured on a scale of 0–21, where lower is better), the reported data shows average score decreases of around 2.0 to 2.2 points across different time points during the study. On the RLS symptom severity scale (scored 0–40, where lower is better), average score decreases of roughly 9.5 to 11.4 points were reported at various visits, and between about 55% and 64% of participants were reported to have had their symptom score reduce by at least half at different time 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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• NCT01455012 · results posted 18 July 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 81 people with Restless Legs Syndrome (RLS) — a condition that causes uncomfortable sensations in the legs, often disrupting sleep. Forty-one participants received a placebo (an inactive treatment) and 40 received rotigotine, a skin-patch medication. The main thing the trial was measuring was the change in the number of times a person's systolic blood pressure (the "top" blood pressure number) spiked during the night in connection with involuntary leg movements during sleep — a pattern linked to RLS. By the end of the four-week treatment period, 30 of the 41 placebo participants and 36 of the 40 rotigotine participants had completed the trial. The reported data shows that, on average, the placebo group had about 80 fewer of these blood pressure spikes per night compared to where they started, while the rotigotine group had about 240 fewer — both groups showed a reduction from their starting point, with the rotigotine group showing a larger reduction in the reported numbers. For the secondary measurements, the reported data shows the rotigotine group also had larger average reductions across several other measures: total overnight blood pressure spikes (roughly 200 fewer vs. roughly 34 fewer for placebo); frequency of leg movements during sleep per hour (about 50 fewer vs. about 15 fewer); and scores on a standard RLS symptom questionnaire, where both groups improved but the rotigotine group's average score dropped by about 18.5 points compared to about 12.5 points for the placebo group (on a scale of 0–40). Quality-of-life scores and a doctor-rated impression of change also showed larger average shifts in the rotigotine group compared to placebo, based on the reported figures. 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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• NCT00991276 · results posted 8 October 2012

  According to the results reported on ClinicalTrials.gov, this trial involved 85 people in total across six groups, each of whom received all three treatments — pregabalin 300 mg, pramipexole 0.5 mg, and a placebo (an inactive dummy treatment) — in a different order, with a short wash-out break between each one. The trial was measuring sleep-related outcomes in people with Restless Legs Syndrome (RLS), using both specialised overnight sleep monitoring (called polysomnography, or PSG) and participants' own reports about their sleep. Not everyone completed all three stages; by the end of the final treatment period, between 8 and 13 people in each group had finished. The reported data shows that the main thing being measured was "Wake After Sleep Onset" (WASO) — that is, how many minutes people were awake after first falling asleep. The reported average figures were approximately 51.5 minutes during the pregabalin period, 78.4 minutes during the pramipexole period, and 78.6 minutes during the placebo period. For several secondary (additional) measures, the reported data shows: the number of limb movements per hour that caused brief wake-ups was approximately 3.9 (pregabalin), 2.7 (pramipexole), and 7.6 (placebo). Participants' own estimates of total sleep time averaged around 401 minutes, 374 minutes, and 370 minutes respectively. The number of times people woke up after falling asleep averaged about 18, 26, and 21 across the three treatment periods. A questionnaire measuring how much RLS affected the next day (scored 0–140, with higher meaning more impact) returned average scores of approximately 41, 46, and 47 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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• NCT01113710 · results posted 28 September 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 687 people who were using a patch called Neupro® (rotigotine) for Restless Legs Syndrome (RLS) — a condition that causes uncomfortable sensations and an urge to move the legs, especially at night. The trial had one group only and no comparison group. Of the 687 who started, 418 completed the study and 269 did not finish. The trial was measuring changes in RLS symptoms and sleep satisfaction using a scoring scale called the RLS-6, where 0 means no problem at all and 10 means the worst possible. The reported data shows the following changes from the start of the study to the end, using that 0–10 scale. For RLS symptoms at bedtime, the average score at the start was 5.2, and the reported average change was −2.2 points (meaning scores moved downward on the scale by that amount). For symptoms during the night, the starting score was 5.5 and the reported change was −2.5 points. For satisfaction with sleep (where a higher score means more dissatisfied), the starting score was 6.4 and the reported change was −2.4 points. For daytime symptoms while resting, the starting score was 5.2 with a reported change of −2.8 points. For daytime symptoms during activity, the starting score was 1.9 with a reported change of −0.9 points. For daytime tiredness, the starting score was 5.1 with a reported change of −1.9 points. Because there was no comparison group, the reported data shows only what changed over time within this single group of 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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• NCT00806026 · results posted 27 September 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT00806026) enrolled 931 people in total across six groups. Participants were assigned to receive either pregabalin (300 mg), one of two doses of pramipexole (0.25 mg or 0.5 mg), or a matching placebo for each of those treatments. The trial was measuring the severity of Restless Legs Syndrome (RLS) symptoms over 12 weeks, using a standard rating scale (scored 0–40, where lower numbers mean fewer or less severe symptoms), as well as how many participants were rated as much improved by their clinician, how many experienced a worsening of symptoms known as "augmentation," and how sleep was affected. The reported data shows that at the start of the trial, all four main groups had similar average RLS severity scores of around 22 out of 40. After 12 weeks, the reported average reductions in that score were: −11.8 points for the pregabalin 300 mg group, −10.5 points for the pramipexole 0.5 mg group, −7.9 points for the pramipexole 0.25 mg group, and −7.3 points for the placebo group. For the proportion of participants whose clinician rated them as "very much improved" or "much improved," the reported figures were 71.4% in the pregabalin group, 62.7% in the pramipexole 0.5 mg group, 51.2% in the pramipexole 0.25 mg group, and 46.8% in the placebo group. Regarding augmentation (a worsening of RLS linked to the treatment itself), the reported data shows it was recorded in 1.7% of the pregabalin group, 6.6% of the pramipexole 0.25 mg group, and 9.0% of the pramipexole 0.5 mg group — this measure was not reported for the placebo group. For sleep, the reported data shows that at the start of the trial participants were spending roughly 80–100 minutes awake after first falling asleep. After 12 weeks, the reported reductions in that time were: about 50 minutes for the pregabalin group, about 37 minutes for the pramipexole 0.5 mg group, about 34 minutes for the pramipexole 0.25 mg group, and about 33 minutes for the placebo group. It is also worth noting that roughly half of all participants across the active treatment groups did not complete the full trial period, though the reasons for this are not detailed 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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• NCT01170091 · results posted 11 September 2012

  According to the results reported on ClinicalTrials.gov, this trial involved 651 people who were all given a medication called Mirapex (pramipexole), which is used for Restless Legs Syndrome (RLS). Of those who started, 627 completed the trial and 24 did not finish. The trial measured the number of side effects (called adverse events) that occurred, how much participants' RLS symptom scores changed, and how both the participants themselves and their doctors rated overall improvement. The reported data shows that for the primary measure — tracking reported side effects — 8, 2, 1, and 1 cases were recorded across different categories (the data does not specify what each category represents beyond the total counts). For the symptom severity score, participants filled in a questionnaire called the IRLS scale, which runs from 0 (no symptoms) to 40 (very severe). The reported data shows an average change of −14.7 points after four weeks of treatment, meaning scores were on average that much lower than at the start. For the participant self-rating (PGI-I), the reported numbers were: 177 said "very much improved," 360 said "much improved," 45 said "minimally improved," 42 said "no change," 2 said "minimally worse," 1 said "much worse," and none said "very much worse." The doctor ratings (CGI-I) were similar: 188 rated as "very much improved," 351 as "much improved," 49 as "minimally improved," 35 as "no change," 3 as "minimally worse," 1 as "much worse," and none as "very much worse." 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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• NCT00479154 · results posted 26 April 2012

  According to the results reported on ClinicalTrials.gov, this trial involved just 6 people in total, split into two small groups of 3. It used a "crossover" design, meaning each participant received both treatments at different times — one group received a placebo (an inactive injection) first and then botulinum toxin (commonly known as Botox), while the other group received them in the opposite order. The trial was measuring changes in Restless Legs Syndrome (RLS) symptoms using a standard rating scale, where scores range from 1 to 40: scores of 1–10 are considered mild, 11–20 moderate, 21–30 severe, and 31–40 very severe. All 6 participants completed the trial. The reported data shows the average change in RLS score two weeks after each type of injection. A negative number means the score went down (i.e., symptoms were rated lower on the scale) compared to where each person started. For the group that received the placebo first and then botulinum toxin, the reported average change was −5.0 points after the placebo and −1.0 points after botulinum toxin. For the group that received botulinum toxin first and then the placebo, the reported average change was −2.7 points after botulinum toxin and −5.0 points after the placebo. No other outcome measures were reported in the submitted data. It is worth noting that with only 6 participants, this was an extremely small study, and the data as reported to ClinicalTrials.gov does not allow for broad conclusions. 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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• NCT00621517 · results posted 5 April 2012

  According to the results reported on ClinicalTrials.gov, this trial looked at bupropion (a medication) compared to a placebo (a dummy treatment with no active ingredient) in people with restless legs syndrome. A total of 60 people took part — 29 in the bupropion group and 31 in the placebo group. Of those, 22 in the bupropion group and 24 in the placebo group completed the study. The trial was measuring changes in restless legs syndrome symptoms over six weeks, using a symptom severity questionnaire, a doctor's overall impression of improvement, and a separate symptom rating scale. The reported data shows results for the main symptom questionnaire, which runs from 0 to 40 points, where higher scores mean more severe symptoms. At three weeks, the bupropion group's average score had dropped by 10.4 points from their starting score, while the placebo group's average score had dropped by 7.6 points. At six weeks, the bupropion group showed an average drop of 10.8 points, compared to 6.0 points in the placebo group. For the other two primary measures — the doctor's overall impression of improvement and the separate symptom rating scale — 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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• NCT01332305 · results posted 26 May 2011

  According to the results reported on ClinicalTrials.gov, this trial (NCT01332305) looked at how the body absorbs and processes a drug called GEn (genobiotics/genomics entity) at four different doses — 600 mg, 1,200 mg, 1,800 mg, and 2,400 mg — compared to a placebo (a dummy treatment with no active ingredient). A total of 217 people started the trial across the five groups, and 159 of them completed it. The trial was not measuring whether the drug treated a condition; instead, it was measuring pharmacokinetics — that is, how the drug moves through the body, including how much of it is absorbed and how quickly. The reported data shows several specific measurements taken while participants were taking the drug regularly (called "steady state"). For peak drug levels in the blood, the four dose groups recorded values of approximately 3.86, 7.14, 11.4, and 14.0 nanograms per millilitre respectively (a nanogram is an extremely tiny unit of measurement). The lowest drug levels between doses were reported as roughly 0.69, 1.37, 1.63, and 2.34 nanograms per millilitre across the four dose groups. The time it took for the drug to reach its peak level in the blood was reported as approximately 8.76, 8.57, 7.61, and 8.01 hours across the groups. A measure of total drug exposure over 24 hours (called AUC — essentially the overall amount of drug the body was exposed to) was reported as approximately 49.3, 96.1, 141, and 176 units across the four doses at week 4, with similar figures at week 12. No data was reported for the placebo group for most of these measurements, and the half-life figures (how long it takes the body to clear half the drug) were reported as approximately 5.82, 6.67, 5.82, and 6.05 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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• NCT00311363 · results posted 25 May 2011

  According to the results reported on ClinicalTrials.gov, this trial involved people with Restless Legs Syndrome (RLS), a condition that causes uncomfortable sensations in the legs and an urge to move them. A total of 327 people started a 24-week open-label phase (where everyone received the study medication, gabapentin enacarbil at 1,200 mg). Of those, 221 completed that phase and went on to a 12-week double-blind phase — meaning neither the participants nor their doctors knew who was receiving the medication or a dummy pill (placebo). In this second phase, 98 participants were assigned to placebo and 96 to the study medication. The reported data shows that the main thing being measured was how many participants experienced a "relapse" — defined as their RLS symptoms worsening beyond a set threshold during the 12-week double-blind phase. According to the results reported on ClinicalTrials.gov, 22.7% of participants in the placebo group experienced a relapse, compared with 9.4% in the medication group. For a secondary measure looking at symptom severity scores (on a scale of 0–40, where higher means more severe), the reported data shows both groups had small changes from their starting score at the beginning of the double-blind phase, with the placebo group showing a change of 3.9 points and the medication group showing a change of 1.9 points by the end of treatment. Another secondary measure asked doctors to rate overall change: 67% of participants in the placebo group and 75% in the medication group were rated as showing "no change or improvement" compared to when the double-blind phase began. The data for time-to-relapse measures was not fully reported, as the median could not be calculated using the statistical method 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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• NCT00365352 · results posted 11 May 2011

  According to the results reported on ClinicalTrials.gov, this trial looked at a medication called gabapentin enacarbil (GEn, also referred to as XP13512/GSK1838262) in people with Restless Legs Syndrome (RLS). A total of 325 people started the trial and were split into three groups: one group received a placebo (a dummy treatment with no active ingredient), one received a 600 mg dose of GEn, and one received a 1,200 mg dose. The trial ran for 12 weeks and measured changes in RLS symptom severity using two tools: the IRLS Rating Scale (a 0–40 point questionnaire where higher scores mean more severe symptoms) and the CGI-I (a 1–7 scale where a doctor rates how much a participant's condition changed overall). The reported data shows that, for the primary outcomes, participants in the placebo group had an average reduction of 9.8 points on the IRLS scale, while those in the 1,200 mg GEn group had an average reduction of 13.0 points. On the doctor-rated CGI-I scale, 43 out of 96 placebo participants were rated as "much improved" or "very much improved" at week 12, compared with 86 out of 111 participants in the 1,200 mg GEn group. For secondary outcomes, the 600 mg GEn group showed an average IRLS score reduction of 13.8 points (compared to 9.8 for placebo), and 83 out of 114 participants in that group were rated as CGI-I responders (compared to 43 for placebo). The reported data also shows that at the end of week 1, 36 participants in the 600 mg group and 40 in the 1,200 mg group met the criteria for an early response, compared to 13 in the placebo group. The median time to first response was reported as 4.1 weeks for the 600 mg group and 2.1 weeks for the 1,200 mg group; a median time was not reported 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.

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• NCT01327339 · results posted 1 April 2011

  According to the results reported on ClinicalTrials.gov, this trial involved 755 people who were given ropinirole (Requip) at doses of 0.25 mg, 1 mg, or 2 mg. Of those who started, 747 completed the study and 8 did not. The trial was primarily focused on tracking and recording any unwanted medical events (called adverse events) that occurred while participants were taking the medication — this is a standard way of monitoring what happens to people during a drug study. The reported data shows that out of 755 participants, 44 experienced at least one adverse event of any kind during the study. For more serious adverse events — defined as those involving death, being life-threatening, requiring hospitalisation, or causing lasting disability — the reported data shows that 3 participants experienced one of these. Additionally, a small number of participants experienced what are described as "unexpected" adverse events, meaning medical events not already listed in the product's approved information. The reported data shows these occurred in very small numbers, with individual unexpected events each affecting just 1 or 2 participants. It is worth noting that this trial recorded and counted these events but did not report a comparison group (such as a placebo or no-treatment group), so the numbers above reflect what was observed in the one group studied. 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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• NCT00887289 · results posted 15 December 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,504 people who were all receiving the medication pramipexole. Of those, 1,409 completed the study, while 95 did not finish. The trial was measuring changes in pain and restless legs syndrome (RLS) symptoms over time, using several standardised questionnaires where participants rated how they were feeling at the start of the study and again later. The reported data shows that, overall, participants' scores on the McGill Pain Questionnaire — a tool that rates pain from 0 (no pain) to 20 (worst pain) — changed by an average of −14.48 points from the start to the end of the study. A negative number on this scale means scores went down (toward less pain). When the results were broken down by type of treating doctor, the reported change was −15.87 points for those seen by a general practitioner and −12.13 points for those seen by a neurologist. For restless legs symptoms, the reported data shows a change of −1.63 points on one RLS scale (rated 0–20) and −17.71 points on a second, longer RLS scale (rated 0–40), with negative numbers again indicating scores moving toward the better end of each scale. The reported data also shows that 8 participants experienced behavioural changes related to impulse control — a term used to describe difficulty resisting urges or behaviours — during the course of treatment. It is important to note that this trial had only one group (everyone received pramipexole), so the reported numbers describe changes within that single group and are not compared against a group that received no treatment or a different treatment. No separate comparison group data was 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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• NCT00329602 · results posted 27 May 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 404 people across two groups for a 26-week double-blind phase — 207 received a placebo (a dummy treatment) and 197 received a medication called ropinirole IR. Participants could not tell which they were receiving. The trial was mainly measuring changes in restless legs syndrome (RLS) symptom severity, using a standard 10-question scale called the IRLS, where scores range from 0 (no symptoms) to 40 (very severe symptoms). A lower score over time means fewer or less severe symptoms. After the double-blind phase, 269 participants moved into a 40-week open-label phase where everyone received ropinirole IR (meaning both participants and researchers knew what was being taken). The reported data shows that, at the 12-week mark, the placebo group's average IRLS score dropped by 12.1 points from where they started, while the ropinirole IR group's average score dropped by 14.2 points. At week 26, the reported drops were 13.4 points for the placebo group and 15.9 points for the ropinirole IR group. The reported data also shows changes across several secondary measures — including sleep quality (measured using a sleep scale called the MOS-12), quality of life related to RLS (using the Johns Hopkins RLS Quality of Life questionnaire), and general wellbeing (using the SF-36 health survey). In each of these measures, both groups showed changes from their starting scores at weeks 12 and 26, with the direction and size of change varying by measure. For example, reported sleep quantity increased by around 0.5 hours in the placebo group and 0.7 hours in the ropinirole IR group at both timepoints. Quality of life scores, where higher means better, rose in both groups across the measured timepoints. 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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• NCT00498186 · results posted 13 April 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 295 participants, all of whom received a treatment called rotigotine. The study was a 5-year open-label extension, meaning all participants knew they were receiving the treatment and were followed over a long period. Of the 295 people who started, 122 completed the full study period, while 173 did not finish. The primary outcome — the main thing the trial was measuring — was how many participants experienced at least one adverse event (that is, any unwanted or unexpected medical occurrence that happened during the study, whether or not it was thought to be related to the treatment). The reported data shows that 273 out of 295 participants had at least one such event recorded during the 5-year period. The secondary outcome measured how many participants left the study early specifically because of an adverse event. The reported data shows that 93 participants withdrew from the trial for this reason. It is important to note that an adverse event as defined in this trial includes any medical occurrence — not necessarily one caused by the treatment itself. The trial did not include a comparison group, so there is no separate group of participants to compare these numbers against. 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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• NCT00676403 · results posted 4 February 2010

  According to the results reported on ClinicalTrials.gov, this trial looked at pregabalin (tested at five different daily doses: 50 mg, 100 mg, 150 mg, 300 mg, and 450 mg) compared to a placebo (a dummy treatment with no active ingredient) in people with Restless Legs Syndrome (RLS). A total of 137 people started the trial across the six groups, with numbers ranging from 22 to 24 people per group. The main thing the trial was measuring was how much participants' RLS symptom scores changed over six weeks, using a standard questionnaire called the IRLS — a 40-point scale where a lower score means fewer or less bothersome symptoms. The reported data shows that all groups, including the placebo group, had lower IRLS scores at six weeks compared to where they started. The placebo group's average score dropped by 7.73 points. Among the pregabalin groups, the reported average score drops were: 11.83 points (50 mg), 11.76 points (100 mg), 16.02 points (150 mg), 12.89 points (300 mg), and 16.26 points (450 mg). For the secondary measures — which looked at things like how a clinician rated overall improvement, time taken to fall asleep, hours of sleep, and number of nighttime wake-ups — the reported data shows changes across all groups, again including the placebo group. For example, the reported data shows that the time taken to fall asleep decreased across all groups, with the largest reported decrease in the 450 mg pregabalin group. Hours of sleep increased slightly across all groups, and the number of nighttime awakenings decreased slightly in all 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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• NCT00721279 · results posted 8 January 2010

  According to the results reported on ClinicalTrials.gov, this trial (NCT00721279) enrolled 549 people with Restless Legs Syndrome (RLS) — a condition that causes uncomfortable sensations in the legs and an urge to move them. Of these, 452 were classed as "de-novo" patients (people who had not previously been treated for RLS) and 97 were "pre-treated" patients (people who had received prior treatment). The trial was measuring the severity of RLS symptoms using a standard 10-question rating scale (scored 0–40, where higher scores mean worse symptoms), as well as a doctor's overall impression of whether each participant's condition had changed over the course of the study. The reported data shows that at the start of the trial, the majority of participants in both groups had symptoms rated as "severe" — around 62% of de-novo patients and 55% of pre-treated patients fell into that category. After 12 weeks, the reported average symptom score had dropped by 17 points in the de-novo group and 16 points in the pre-treated group. Regarding the doctor's overall impression of change, the reported data shows that approximately 47% of de-novo patients and 45% of pre-treated patients were rated as "very much improved," while a further 46% and 42% respectively were rated as "much improved." A small proportion — around 3% of de-novo and 8% of pre-treated patients — were rated as "minimally improved." The reported data on adverse events (unwanted health events noted during the trial) showed that 25 out of the overall group experienced any adverse event, 7 experienced an adverse event considered related to the treatment, and 2 experienced a serious adverse event. No further breakdown of these adverse events was 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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• NCT00472199 · results posted 17 November 2009

  According to the results reported on ClinicalTrials.gov, this trial looked at a medication called pramipexole compared to a placebo (a dummy treatment with no active ingredient) in people with Restless Legs Syndrome (RLS). A total of 166 people were assigned to pramipexole and 163 to placebo. The trial ran for 26 weeks and measured changes in RLS symptom severity using several rating scales, where higher scores mean worse symptoms. The reported data shows that the main thing being measured was change in a standard RLS symptom score (rated 0–40, with 40 being the most severe). After 26 weeks, the pramipexole group's average score dropped by 13.7 points from where it started, while the placebo group's average score dropped by 11.1 points. For a secondary measure — where people rated themselves as "much improved" or "very much improved" on a global impression scale — 111 out of 166 people in the pramipexole group and 80 out of 163 in the placebo group met that threshold. On a separate measure looking at whether people's RLS score fell by at least half, 95 pramipexole participants and 68 placebo participants reached that mark. Two further scales measuring difficulty falling asleep and satisfaction with sleep also showed score reductions in both groups, with the pramipexole group reporting somewhat larger drops on both. It is worth noting that more people in the placebo group did not complete the trial (60 out of 163) compared to the pramipexole group (35 out of 166), which the reported data notes but does not fully explain. 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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• NCT00357097 · results posted 16 September 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 266 people in total — 199 were given ropinirole and 67 received a placebo (a dummy treatment with no active ingredient). Of those, 145 in the ropinirole group and 38 in the placebo group completed the full 12 weeks. The trial was measuring changes in depression symptoms over that period, using three different questionnaire-based rating scales completed by clinicians and participants themselves. The reported data shows the following average changes in scores after 12 weeks. On the main (primary) measure — the MADRS scale, where a higher score means more severe depression symptoms and scores run from 0 to 60 — the ropinirole group's average score dropped by 10.1 points from where they started, while the placebo group's average score dropped by 6.5 points. For a sub-group who began the trial with at least moderate depression on this scale, the reported drops were 12.5 points for ropinirole and 8.8 points for placebo. On the clinician-rated HAM-D scale (0–54), the reported average drops were 8.2 points (ropinirole) versus 5.5 points (placebo) across all participants, and 9.6 versus 7.2 points in those who started with at least moderate depression. On the self-reported Beck Depression Inventory (0–63), the reported average drops were 8.6 points (ropinirole) versus 6.5 points (placebo) overall, and 10.9 versus 9.9 points in those who started with at least mild-to-moderate depression on that scale. All three scales showed reductions in reported scores in both groups over the 12 weeks, with the ropinirole group generally showing larger average reductions than the placebo group across the measures listed. The reported data does not include information about side effects or safety outcomes in this submission. 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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• NCT00389831 · results posted 4 September 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 44 people in total — 10 in a placebo group and 34 in a rotigotine nasal spray group. The trial was looking at a nasal spray form of a medicine called rotigotine in people with Restless Legs Syndrome (RLS). It measured two things after a single dose: how severe participants rated their RLS symptoms on a 0–10 scale (where 0 means no severity and 10 means very severe), and how often participants experienced involuntary leg movements while awake, counted as movements per hour. All 10 placebo participants completed the study, while 27 of the 34 in the rotigotine group completed it, with 7 not finishing. The reported data shows the following symptom severity scores (on the 0–10 scale): across the four placebo days, scores were 2.6, 2.2, 2.5, and 2.0. In the rotigotine nasal spray group, the placebo phase scored 2.9, the 62 microgram dose scored 2.7, the 124 microgram dose scored 2.0, and the 247 microgram dose scored 1.5. For leg movement frequency (movements per hour while awake), the reported data shows placebo group figures of 37.8, 22.6, 34.9, and 19.0 across the four days. In the rotigotine nasal spray group, the figures were 28.7 (placebo phase), 25.4 (62 micrograms), 26.2 (124 micrograms), and 20.2 (247 micrograms). 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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• NCT00390689 · results posted 25 August 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 154 people across three groups, each taking a different daily dose of a medicine called pramipexole — 0.25 mg, 0.5 mg, or 0.75 mg — to treat Restless Legs Syndrome (RLS). The trial ran for six weeks and the main thing it was measuring was how much participants' RLS symptom scores changed over that time, using a standard questionnaire called the IRLS scale, which runs from 0 (no symptoms) to 40 (very severe symptoms). The trial also looked at sleep quality, daytime sleepiness, and how both doctors and patients rated overall improvement. Of the 154 who started, 141 completed the trial. The reported data shows that the main goal of the trial was to see whether the average IRLS score dropped by 10 or more points (which represents a meaningful step down in symptom severity) in each dose group. According to the results reported on ClinicalTrials.gov, the average score fell by 12.3 points in the 0.25 mg group, 12.5 points in the 0.5 mg group, and 11.8 points in the 0.75 mg group — all exceeding that 10-point threshold. For the secondary measures, around 49–60% of participants in each group had their IRLS score cut in half or more. Sleep quality scores (on a 0–21 scale, lower being better) dropped by roughly 2.5 to 3.2 points across groups, and daytime sleepiness scores (on a 0–24 scale, lower being better) dropped by around 2.3 to 3.0 points. When doctors rated overall improvement, approximately 70–77% of participants in each group were rated as "very much improved" or "much improved"; when participants rated themselves, approximately 68–79% gave the same top two ratings. 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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• NCT00530790 · results posted 24 July 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 35 adults who all received a controlled-release form of a medication called ropinirole, which was being studied in people with Restless Legs Syndrome (RLS). There was no comparison or placebo group — everyone received the same treatment. Of the 35 who started, 30 completed the trial and 5 did not finish. The trial tracked drug-related unwanted events, as well as changes in RLS symptom severity, sleep quality, and doctors' overall impressions of participants' condition, all measured over 12 weeks. The reported data shows that across all participants, a total of 29 drug-related adverse events (unwanted reactions considered possibly linked to the medication) were recorded during the study, with individual event types occurring between 1 and 14 times each. For RLS symptom severity, participants were scored on a standard rating scale where higher numbers mean more severe symptoms. The reported data shows the average score at the start was 25.3 points (in the "severe" range), and at week 12 the average score was 6.0 points (in the "mild" range), representing an average change of −19.3 points. For sleep quality, average scores fell from 9.4 to 5.4 points, a reported change of −4.2 points. On the doctor-rated severity scale at week 12, most participants were rated in the "moderate" or lower categories, compared to mostly "moderate" to "marked" severity at the start. On the global improvement scale at week 12, the reported data shows 21 out of a subset of participants were rated as "much improved" or "very much improved." 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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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.