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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.

MeSH D012148 Nervous System Diseases C10 F03
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Phase 1 Phase 1 8 Phase 1/2 Phase 1/2 6 Phase 2 Phase 2 34 Phase 2/3 Phase 2/3 6 Phase 3 Phase 3 38 Phase 4 Phase 4 30 Not applicable Not applicable 79 Observational Observational 50 Phase 1 Phase 1 8 Phase 1/2 Phase 1/2 6 Phase 2 Phase 2 34 Phase 2/3 Phase 2/3 6 Phase 3 Phase 3 38 Phase 4 Phase 4 30 Not applicable Not applicable 79 Observational Observational 50

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.

Get the Restless Legs Syndrome report as a PDF

The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

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

1995: 1 trials (Observational 1) 2001: 1 trials (Phase 4 1) 2002: 3 trials (Phase 3 2, Phase 2 1) 2003: 8 trials (Observational 2, Phase 3 3, Phase 2 3) 2004: 5 trials (Not applicable 2, Phase 3 2, Phase 2 1) 2005: 14 trials (Not applicable 2, Phase 3 9, Phase 2 1, Phase 1/2 1, Phase 1 1) 2006: 24 trials (Observational 3, Not applicable 1, Phase 4 6, Phase 3 7, Phase 2 5, Phase 1 2) 2007: 14 trials (Observational 5, Not applicable 1, Phase 4 2, Phase 3 1, Phase 2 4, Phase 1/2 1) 2008: 8 trials (Observational 1, Not applicable 1, Phase 3 2, Phase 2/3 2, Phase 2 2) 2009: 11 trials (Observational 3, Not applicable 3, Phase 4 1, Phase 3 1, Phase 2 3) 2010: 6 trials (Observational 4, Phase 3 1, Phase 2/3 1) 2011: 9 trials (Observational 3, Phase 4 1, Phase 2 3, Phase 1 2) 2012: 13 trials (Observational 3, Not applicable 3, Phase 4 2, Phase 3 2, Phase 2 2, Phase 1 1) 2013: 5 trials (Observational 1, Not applicable 2, Phase 4 2) 2014: 10 trials (Observational 3, Not applicable 2, Phase 4 3, Phase 3 1, Phase 2 1) 2015: 7 trials (Observational 1, Not applicable 2, Phase 4 1, Phase 3 1, Phase 2/3 1, Phase 2 1) 2016: 10 trials (Observational 1, Not applicable 5, Phase 4 3, Phase 1 1) 2017: 6 trials (Observational 1, Not applicable 2, Phase 4 1, Phase 2 1, Phase 1/2 1) 2018: 5 trials (Observational 1, Not applicable 2, Phase 3 1, Phase 2 1) 2019: 12 trials (Not applicable 7, Phase 4 1, Phase 3 2, Phase 2 2) 2020: 9 trials (Observational 3, Not applicable 4, Phase 4 1, Phase 3 1) 2021: 11 trials (Observational 3, Not applicable 7, Phase 4 1) 2022: 12 trials (Observational 3, Not applicable 3, Phase 4 3, Phase 3 1, Phase 2/3 1, Phase 2 1) 2023: 6 trials (Observational 1, Not applicable 4, Phase 4 1) 2024: 10 trials (Observational 3, Not applicable 5, Phase 1/2 2) 2025: 19 trials (Observational 4, Not applicable 14, Phase 2/3 1)

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.

Trials started per year
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

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
Trials by phase
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.

Trials by recruitment status
Status Trials
Not yet recruiting 11
Recruiting 21
Enrolling by invitation 1
Active, not recruiting 6
Completed 166

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.

Lead sponsors
Sponsor Trials
Boehringer Ingelheim 20
GlaxoSmithKline 16
XenoPort, Inc. 14
UCB Pharma 10
Noctrix Health, Inc. 9

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.

Drugs tested
Drug Trials
Gabapentin Enacarbil 15
Ropinirole 11
Pregabalin 5
Fer-In-Sol 4
Clorazepate Dipotassium 4

Interventions as named in the registry (9)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
Pramipexole ER 19
Rotigotine TTS (Test) 14
Ferricarboxymaltose 6
Ropinirole Extended Release (XR) 3
Low Dose Suvorexant 2

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.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Osteoarthritis 13 3
Inpatient hospitalization 7 1
Appendicitis 6 5
Myocardial infarction 6 3
Pneumonia 5 5

Which publications cover Restless Legs Syndrome? (237)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: prevalence, rare-disease identity, and sub-conditions in mesh.

Browse all condition evidence pages