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ClinicalTrials.gov public records Last synced Sep 5, 2026, 4:28 PM EDT

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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: RLS Clear all
Active, not recruiting Phase 4 Interventional

Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy

NCT05003648
View directory record Official record
Conditions
Adrenoleukodystrophy, Restless Legs Syndrome
Interventions
Pramipexole, Placebo
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 75 Years · Female only
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jun 30, 2026 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 3 Interventional Results available

Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

NCT00806026
View directory record Official record
Conditions
Idiopathic Restless Legs Syndrome
Interventions
placebo and pregabalin, pramipexol, Pregabalin
Drug
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Industry
Eligibility
18 Years and older
Enrollment
731 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
42
States / cities
Birmingham, Alabama • Jasper, Alabama • Tuscaloosa, Alabama + 35 more
Source: ClinicalTrials.gov public record
Updated Jan 25, 2021 · Synced Sep 5, 2026, 4:28 PM EDT
Not listed Phase 4 Interventional

An Efficacy and Safety Evaluation of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS

NCT02560766
View directory record Official record
Conditions
RLS
Interventions
HORIZANT 300 mg, HORIZANT 600 mg, Placebo
Drug
Lead sponsor
XenoPort, Inc.
Industry
Eligibility
13 Years to 17 Years
Enrollment
132 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2023
U.S. locations
12
States / cities
Redwood City, California • Gulf Breeze, Florida • Winter Park, Florida + 9 more
Source: ClinicalTrials.gov public record
Updated Jun 8, 2021 · Synced Sep 5, 2026, 4:28 PM EDT
Recruiting Not applicable Interventional

Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome

NCT07144631
View directory record Official record
Conditions
Restless Leg Disorder, Restless Leg Syndrome (RLS), Pregnancy, Sleep Disorder (Disorder)
Interventions
Peroneal Nerve Stimulation (PNS) Device
Device
Lead sponsor
Rhode Island Hospital
Other
Eligibility
18 Years and older · Female only
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Nov 11, 2025 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 3 Interventional

Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome

NCT00197080
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
Ropinirole Extended Release (XR)
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 79 Years
Enrollment
380 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2006
U.S. locations
60
States / cities
Alabaster, Alabama • Jasper, Alabama • Mesa, Arizona + 55 more
Source: ClinicalTrials.gov public record
Updated Sep 22, 2016 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 3 Interventional

RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole

NCT00314860
View directory record Official record
Conditions
Restless Legs Syndrome, Restless Legs Syndrome (RLS)
Interventions
ropinirole Extended Release (XR)
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 79 Years
Enrollment
568 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006
U.S. locations
28
States / cities
Birmingham, Alabama • Mesa, Arizona • Phoenix, Arizona + 25 more
Source: ClinicalTrials.gov public record
Updated Oct 17, 2016 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 2 Interventional

Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)

NCT01521663
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
IPX159, Placebo
Drug
Lead sponsor
Impax Laboratories, LLC
Industry
Eligibility
18 Years to 70 Years
Enrollment
159 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
38
States / cities
Brimingham, Alabama • Little Rock, Arkansas • La Jolla, California + 34 more
Source: ClinicalTrials.gov public record
Updated Jan 31, 2017 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole

NCT00422994
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
ropinirole dosing for up to 28 days
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 79 Years
Enrollment
48 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2006
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Oct 25, 2016 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 2 Interventional

The Effects of Aplindore on the Treatment of Signs and Symptoms of Restless Legs Syndrome

NCT00626418
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
Aplindore, Placebo
Drug
Lead sponsor
Ligand Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2008
U.S. locations
5
States / cities
Hallandale, Florida • Atlanta, Georgia • Crestview Hills, Kentucky + 2 more
Source: ClinicalTrials.gov public record
Updated Oct 2, 2011 · Synced Sep 5, 2026, 4:28 PM EDT
Terminated Phase 2 Interventional Results available

Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia

NCT02826681
View directory record Official record
Conditions
Restless Legs Syndrome (RLS)
Interventions
Injectafer® (Ferric Carboxymaltose - FCM), Placebo (Normal Saline)
Drug
Lead sponsor
American Regent, Inc.
Industry
Eligibility
18 Years and older
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
8
States / cities
Lemon Grove, California • Fort Myers, Florida • Orlando, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Apr 10, 2025 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 2 Interventional Results available

Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome

NCT01495793
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
Rotigotine
Drug
Lead sponsor
UCB BIOSCIENCES, Inc.
Industry
Eligibility
13 Years to 17 Years
Enrollment
42 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
12
States / cities
Little Rock, Arkansas • Los Angeles, California • Orange, California + 9 more
Source: ClinicalTrials.gov public record
Updated Apr 3, 2018 · Synced Sep 5, 2026, 4:28 PM EDT
Completed No phase listed Observational

Neuronal Ceroid Lipofuscinosis and Associated Sleep Abnormalities

NCT01966757
View directory record Official record
Conditions
Neuronal Ceroid Lipofuscinosis, Batten's Disease
Interventions
Not listed
Lead sponsor
Nationwide Children's Hospital
Other
Eligibility
Not listed
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Jul 25, 2016 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Botulinum Toxin to Treat Restless Legs Syndrome

NCT00479154
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
Botulinum Toxin A
Drug
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Eligibility
18 Years to 80 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Apr 25, 2012 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 2 Interventional

Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome

NCT01617044
View directory record Official record
Conditions
Iron Deficiency, Restless Leg Syndrome
Interventions
Probiotics, Placebo
Dietary Supplement
Lead sponsor
Children's Hospitals and Clinics of Minnesota
Other
Eligibility
5 Years to 18 Years
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
1
States / cities
Saint Paul, Minnesota
Source: ClinicalTrials.gov public record
Updated Jan 19, 2016 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 2 Interventional Results available

Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome.

NCT01931878
View directory record Official record
Conditions
Restless Leg Syndrome
Interventions
incobotulinumtoxinA, Placebo
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Mar 20, 2016 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 3 Interventional Results available

Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance

NCT00748098
View directory record Official record
Conditions
Restless Legs Syndrome, Restless Legs Syndrome (RLS)
Interventions
GSK1838262 Extended Release Tablets, Placebo
Drug
Lead sponsor
XenoPort, Inc.
Industry
Eligibility
18 Years and older
Enrollment
136 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
24
States / cities
Jasper, Alabama • San Diego, California • Hallandale, Florida + 20 more
Source: ClinicalTrials.gov public record
Updated Jul 21, 2013 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 4 Interventional

A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS

NCT00375284
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
Pramipexole
Drug
Lead sponsor
Boehringer Ingelheim
Industry
Eligibility
18 Years to 80 Years
Enrollment
404 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2006
U.S. locations
52
States / cities
Birmingham, Alabama • Dothan, Alabama • Mesa, Arizona + 47 more
Source: ClinicalTrials.gov public record
Updated Oct 30, 2013 · Synced Sep 5, 2026, 4:28 PM EDT
Completed No phase listed Observational

Impact of Iron Supplementation Treatment on Brain Iron Concentrations

NCT04144790
View directory record Official record
Conditions
ADHD, Iron-deficiency, Restless Legs Syndrome, Periodic Limb Movement Sleep Disorder
Interventions
ferrous sulfate
Dietary Supplement
Lead sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Other
Eligibility
5 Years to 18 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Oct 13, 2025 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 3 Interventional Results available

A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis

NCT01537042
View directory record Official record
Conditions
Restless Legs Syndrome, End-Stage Renal Disease
Interventions
Rotigotine, Placebo
Drug
Lead sponsor
UCB BIOSCIENCES GmbH
Industry
Eligibility
18 Years to 85 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
6
States / cities
Brandon, Florida • Newton, Massachusetts • West Seneca, New York + 3 more
Source: ClinicalTrials.gov public record
Updated Nov 2, 2014 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 2 Interventional Results available

Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome

NCT01332305
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
GEn (XP13512/GSK1838262), Placebo
Drug
Lead sponsor
XenoPort, Inc.
Industry
Eligibility
18 Years and older
Enrollment
217 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Jul 21, 2013 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate the Effect of Gabapentin on Cardiac Repolarization in Healthy Volunteers

NCT01516372
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
GEn 1200mg, Gen 6000 mg, GEn Placebo, Moxifloxacin Placebo, Moxifloxacin
Drug
Lead sponsor
XenoPort, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
52 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Apr 11, 2021 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 3 Interventional

A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

NCT00363857
View directory record Official record
Conditions
Restless Legs Syndrome (RLS), Restless Legs Syndrome
Interventions
Ropinirole
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 79 Years
Enrollment
360 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2004
U.S. locations
49
States / cities
Alabaster, Alabama • Birmingham, Alabama • Jasper, Alabama + 44 more
Source: ClinicalTrials.gov public record
Updated Oct 16, 2016 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 3 Interventional Results available

Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance

NCT00991276
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
pregabalin, placebo, pramipexole
Drug
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Industry
Eligibility
18 Years and older
Enrollment
85 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
41
States / cities
Jasper, Alabama • Phoenix, Arizona • Tucson, Arizona + 35 more
Source: ClinicalTrials.gov public record
Updated Feb 14, 2021 · Synced Sep 5, 2026, 4:28 PM EDT
Completed Phase 2 Interventional

A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS)

NCT00247364
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
Levetiracetam (Keppra)
Drug
Lead sponsor
Sleep Health Centers
Other
Eligibility
18 Years to 85 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2005
U.S. locations
1
States / cities
Newton, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 31, 2005 · Synced Sep 5, 2026, 4:28 PM EDT