What changed for Restless Legs Syndrome
A plain English summary of what recently moved in the public data Voxsanity tracks for Restless Legs Syndrome. Updated from government registries. Not medical advice.
How to read these changes: every figure on this page is the difference between two snapshots of what Voxsanity had tracked on each date. Voxsanity only began taking daily snapshots in July 2026 and is still ingesting the public registries, so a rise here is mostly our own coverage expanding rather than new research appearing. Read it as our tracked coverage growing, not as a claim about real-world research changing this fast: it overstates how much actually changed.
Comparing the two most recent snapshots, 27 July 2026 and 28 July 2026.
- Trials recruiting worldwide 24 to 23 (-1)
- Trials on record 242 to 229 (-13)
Newly subsidised on the PBS
No PBS-reviewed medicines are tracked for Restless Legs Syndrome yet, so new PBS listings cannot be reported for it. This is a gap in what Voxsanity has mapped, not a statement that no medicines are subsidised — check the PBS directly.
Past updates
Tracking began in July 2026. Month on month changes will appear here once a second month of data has been recorded. Until then, the comparison above shows the most recent movement.
Recent trend
Weekly, most recent weeks (fills out to a monthly trend as history grows).
Recent trial results
The 30 most recent of 46 trials tracked for Restless Legs Syndrome that have reported results to a public registry.
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
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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 th...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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 d...
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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 us...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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 wel...
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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 t...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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...
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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....
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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 sympto...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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...
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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 l...
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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 s...
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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...
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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...
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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 tha...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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 sic...
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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 p...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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 f...
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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 movem...
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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 partic...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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 m...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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 symp...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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 sympt...
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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 t...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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...
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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 fina...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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 w...
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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 w...
See all 46 reported results for Restless Legs Syndrome
These are the results as reported to the registry, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
What is coming
AI generated pipeline 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
According to NIH funding data, a moderate amount of public research funding is currently directed toward Restless Legs Syndrome, and the level has remained broadly steady from one year to the next. For patients, this suggests the condition holds a consistent place on the research agenda, without signs of major expansion or contraction in scientific interest. Steady funding can support ongoing stud...
See the full Restless Legs Syndrome page
Not medical advice. Voxsanity republishes public government health data in plain English. These figures describe research and registry activity, not the suitability of any treatment for any person. Trial status can change; always verify current status directly with the trial site and confirm Australian availability with your doctor.