Condition (MeSH)
Restless Legs Syndrome
ClinicalTrials.gov lists 251 trials for Restless Legs Syndrome or a narrower condition beneath it. Boehringer Ingelheim has the most among industry and government lead sponsors, with 20.
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Trials per phase
251 of the 251 trials are tagged with Restless Legs Syndrome itself; the rest are tagged with a narrower condition beneath it.
When did Restless Legs Syndrome trials start? (27)
Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 1 trial is registered to start in 2027 or later, and not listed here.
Trials over time, by phase
- Phase 1
- Phase 1/2
- Phase 2
- Phase 2/3
- Phase 3
- Phase 4
- Not applicable
- Observational
Top of scale: 24
Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.
| Year | Trials started |
|---|---|
| 2026 (partial year) | 10 |
| 2025 | 19 |
| 2024 | 10 |
| 2023 | 6 |
| 2022 | 12 |
| 2021 | 11 |
| 2020 | 9 |
| 2019 | 12 |
| 2018 | 5 |
| 2017 | 6 |
Showing 10 of 27 earlier years.
Forecast of the full-year count, planned starts included, not rows of this table: about 10 trials starting in 2026 and about 15 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 28 percent and ran about 20 percent low against the count later registered; forecasts made before the year began were off by about 39 percent and ran about 37 percent low against the count later registered. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored. The 2026 forecast is below the 10 already registered with a 2026 start date: at the cutoff, 4 trials were already registered to start in October to December, more than the method's monthly average allows for, and the method does not use those planned starts.
Prediction, not a registry value: median of 25 months from start to primary completion across 13 trials still running at the 2026-10-09 snapshot; registered median of 15 months across 171 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
What phase are Restless Legs Syndrome trials in? (8)
Shown in this order: phase order.
Show the trials by phase as a table
| Phase | Trials |
|---|---|
| Phase 1 | 8 |
| Phase 1/2 | 6 |
| Phase 2 | 34 |
| Phase 2/3 | 6 |
| Phase 3 | 38 |
| Phase 4 | 30 |
| Not applicable | 79 |
| Observational | 50 |
How many Restless Legs Syndrome trials are recruiting? (9)
Shown in this order: the order a trial moves through, from not yet recruiting to unknown.
| Status | Trials |
|---|---|
| Not yet recruiting | 11 |
| Recruiting | 21 |
| Enrolling by invitation | 1 |
| Active, not recruiting | 6 |
| Completed | 166 |
Showing 5 of 9 statuses.
Status as registered on ClinicalTrials.gov. Each trial is counted once.
Which lead sponsors run the most Restless Legs Syndrome trials? (9)
Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.
| Sponsor | Trials |
|---|---|
| Boehringer Ingelheim | 20 |
| GlaxoSmithKline | 16 |
| XenoPort, Inc. | 14 |
| UCB Pharma | 10 |
| Noctrix Health, Inc. | 9 |
Showing 5 of 9 sponsors.
Which drugs are being tested for Restless Legs Syndrome? (6)
Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.
| Drug | Trials |
|---|---|
| Gabapentin Enacarbil | 15 |
| Ropinirole | 11 |
| Pregabalin | 5 |
| Fer-In-Sol | 4 |
| Clorazepate Dipotassium | 4 |
Showing 5 of 6 drugs.
Interventions as named in the registry (9)
Shown in this order: most trials first.
| Drug | Trials |
|---|---|
| Pramipexole ER | 19 |
| Rotigotine TTS (Test) | 14 |
| Ferricarboxymaltose | 6 |
| Ropinirole Extended Release (XR) | 3 |
| Low Dose Suvorexant | 2 |
Showing 5 of 9 interventions.
These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.
Which serious adverse events do Restless Legs Syndrome trials report? (10)
Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.
| Adverse event | Subjects affected | Trials |
|---|---|---|
| Osteoarthritis | 13 | 3 |
| Inpatient hospitalization | 7 | 1 |
| Appendicitis | 6 | 5 |
| Myocardial infarction | 6 | 3 |
| Pneumonia | 5 | 5 |
Showing 5 of 10 adverse events.
Which publications cover Restless Legs Syndrome? (237)
Shown in this order: major-topic papers first, then newest, then most linked to trials.
| Publication | Journal | Year | Major topic |
|---|---|---|---|
| Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline. | Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine | 2025 | Yes |
| Progressive muscle relaxation versus manual lymphatic drainage on restless leg syndrome and sleep quality in hemodialysis patients: Randomized Controlled Trial. | Journal of bodywork and movement therapies | 2025 | Yes |
| Long latency trigemino-cervical reflex in restless legs syndrome. | The International journal of neuroscience | 2024 | Yes |
| Functional recovery after ischemic stroke: Impact of different sleep health parameters. | Journal of sleep research | 2024 | Yes |
| Clinical efficacy and safety of intravenous ferric carboxymaltose for treatment of restless legs syndrome: a multicenter, randomized, placebo-controlled clinical trial. | Sleep | 2024 | Yes |
Showing 5 of 237 publications.
Not on this page
Not measured: delivery record.
Checked, with nothing recorded for this condition: prevalence, rare-disease identity, and sub-conditions in mesh.