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Showing 1–24 of 109 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Restless Legs Syndrome, Clear all
Completed Phase 3 Interventional

Long-Term Safety Of Ropinirole XR In Patients With Restless Legs Syndrome

NCT00355641
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
Ropinirole Extended Release (XR)
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years and older
Enrollment
450 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
59
States / cities
Alabaster, Alabama • Jasper, Alabama • Mesa, Arizona + 54 more
Source: ClinicalTrials.gov public record
Updated Oct 27, 2016 · Synced Sep 8, 2026, 11:51 AM EDT
Completed Phase 2 Interventional Results available

Intravenous Iron Metabolism in Restless Legs Syndrome

NCT00685815
View directory record Official record
Conditions
Restless Legs
Interventions
Ferric Carboxymaltose (FCM), Placebo
Drug
Lead sponsor
American Regent, Inc.
Industry
Eligibility
18 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2012
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated May 5, 2025 · Synced Sep 8, 2026, 11:51 AM EDT
Withdrawn Not applicable Interventional

Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study

NCT01861652
View directory record Official record
Conditions
Restless Legs Syndrome,, Restless Legs,, Ekbom Syndrome
Interventions
Venous Health Systems Vasculaire Leg Compression Device
Device
Lead sponsor
Walter Reed National Military Medical Center
Federal
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2013
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Jun 15, 2015 · Synced Sep 8, 2026, 11:51 AM EDT
Completed Phase 3 Interventional Results available

Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS

NCT02397057
View directory record Official record
Conditions
Restless Legs Syndrome (RLS)
Interventions
Injectafer, Placebo
Drug · Other
Lead sponsor
American Regent, Inc.
Industry
Eligibility
18 Years and older
Enrollment
209 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
19
States / cities
Mobile, Alabama • National City, California • Rancho Mirage, California + 15 more
Source: ClinicalTrials.gov public record
Updated Oct 11, 2021 · Synced Sep 8, 2026, 11:51 AM EDT
Completed No phase listed Observational Accepts healthy volunteers

Akathisia (Restless Legs Syndrome) in People With Schizophrenia and Mental Retardation

NCT00065286
View directory record Official record
Conditions
Akathisia
Interventions
Not listed
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Eligibility
18 Years to 60 Years
Healthy volunteers
Accepts healthy volunteers
Timeline
1996 – 1999
U.S. locations
2
States / cities
Morganton, North Carolina • University Park, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jun 23, 2005 · Synced Sep 8, 2026, 11:51 AM EDT
Not yet recruiting Not applicable Interventional

Neuromodulation to Overcome Severe Restless Legs Syndrome

NCT07780032
View directory record Official record
Conditions
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Interventions
Spinal Cord Stimulation
Device
Lead sponsor
Marshall Holland
Other
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2034
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Aug 20, 2026 · Synced Sep 8, 2026, 11:51 AM EDT
Completed Phase 3 Interventional

An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome

NCT00263068
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
Rotigotine
Drug
Lead sponsor
UCB Pharma
Industry
Eligibility
18 Years and older
Enrollment
279 participants
Timeline
2005 – 2007
U.S. locations
1
States / cities
RTP, North Carolina
Source: ClinicalTrials.gov public record
Updated Sep 24, 2014 · Synced Sep 8, 2026, 11:51 AM EDT
Active, not recruiting No phase listed Observational

A Post-Market Study for Long-Term Effectiveness and Safety of the TOMAC System for RLS

NCT06076499
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
NTX100
Device
Lead sponsor
Noctrix Health, Inc.
Industry
Eligibility
21 Years and older
Enrollment
325 participants
Timeline
2023 – 2027
U.S. locations
7
States / cities
Downey, California • San Ramon, California • Newton, Massachusetts + 4 more
Source: ClinicalTrials.gov public record
Updated May 26, 2026 · Synced Sep 8, 2026, 11:51 AM EDT
Recruiting Phase 4 Interventional

Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease

NCT03082755
View directory record Official record
Conditions
Alzheimer Disease
Interventions
Gabapentin Enacarbil, Placebo Oral Tablet
Drug
Lead sponsor
University of Texas at Austin
Other
Eligibility
55 Years and older
Enrollment
156 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2023
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated May 17, 2022 · Synced Sep 8, 2026, 11:51 AM EDT
Not listed Not applicable Interventional

Neuroma Injections to Treat Restless Legs Syndrome - RCT

NCT00656110
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
equal parts of 0.5% plain Marcaine and 2% lidocaine mixed with 0.8 mg Depo-medrol/4% absolute alcohol in a total injection volume of 1 ml, Normal saline - 1ml
Drug
Lead sponsor
Lowcountry Infectious Diseases
Other
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Mar 9, 2009 · Synced Sep 8, 2026, 11:51 AM 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 8, 2026, 11:51 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers Results available

Spinal Cord Stimulation for Restless Legs Syndrome

NCT03539081
View directory record Official record
Conditions
Restless Legs Syndrome, Neuropathic Pain
Interventions
Dual-energy X-ray absorptiometry Scan, Laboratory Measurements, Blood Flow Measurement, Continuous Blood Pressure, Partial pressure of oxygen, Microneurography, Anthropometric Measurements, John Hopkins Restless Legs Severity Scale, Continuous Blood Pressure Diary
Diagnostic Test · Other · Behavioral
Lead sponsor
Marshall Holland
Other
Eligibility
18 Years to 85 Years
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2020
U.S. locations
1
States / cities
Iowa City, Iowa
Source: ClinicalTrials.gov public record
Updated Sep 20, 2023 · Synced Sep 8, 2026, 11:51 AM EDT
Completed Phase 4 Interventional Results available

Switching From Oral Dopamine Agonists to Rotigotine

NCT01976871
View directory record Official record
Conditions
Restless Legs Syndrome, Ekbom Syndrome, Willis-Ekbom Disease
Interventions
Rotigotine
Drug
Lead sponsor
John Winkelman, MD, PhD
Other
Eligibility
18 Years to 75 Years
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Nov 28, 2016 · Synced Sep 8, 2026, 11:51 AM EDT
Terminated Phase 3 Interventional Results available

A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome

NCT03992196
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
Rotigotine 1 mg/24 h, Rotigotine 2 mg/24 h, Rotigotine 3 mg/24 h
Drug
Lead sponsor
UCB Biopharma SRL
Industry
Eligibility
13 Years to 17 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
1
States / cities
Culver City, California
Source: ClinicalTrials.gov public record
Updated Oct 29, 2023 · Synced Sep 8, 2026, 11:51 AM 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 8, 2026, 11:51 AM 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 8, 2026, 11:51 AM 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 8, 2026, 11:51 AM EDT
Not listed Phase 4 Interventional

Pitolisant in Refractory Restless Legs Syndrome

NCT05581576
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
Pitolisant
Drug
Lead sponsor
William Ondo, MD
Other
Eligibility
21 Years to 80 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Oct 13, 2022 · Synced Sep 8, 2026, 11:51 AM 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 8, 2026, 11:51 AM EDT
Completed Not applicable Interventional

Efficacy of BIPAMS for Restless Legs Syndrome in Adults With Multiple Sclerosis: A Pilot Study

NCT04061681
View directory record Official record
Conditions
Multiple Sclerosis, Restless Legs Syndrome
Interventions
Behavioral Intervention (BIPAMS)
Behavioral
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Dec 10, 2020 · Synced Sep 8, 2026, 11:51 AM EDT
Completed Phase 3 Interventional

Sequential Compression Devices for Treatment of Restless Legs Syndrome

NCT00479531
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
AirCast Sequential Compression Device
Device
Lead sponsor
Walter Reed Army Medical Center
Federal
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
1
States / cities
Sleep Disorders Center, Walter Reed Army Medical Center, District of Columbia
Source: ClinicalTrials.gov public record
Updated Nov 29, 2007 · Synced Sep 8, 2026, 11:51 AM 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 8, 2026, 11:51 AM EDT
Not listed Phase 4 Interventional

An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS

NCT02633683
View directory record Official record
Conditions
RLS
Interventions
HORIZANT 600 mg
Drug
Lead sponsor
XenoPort, Inc.
Industry
Eligibility
13 Years to 17 Years
Enrollment
144 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2024
U.S. locations
11
States / cities
Redwood City, California • San Diego, California • Gulf Breeze, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Jun 8, 2021 · Synced Sep 8, 2026, 11:51 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Validating the Use of a Subjectively Reported Sleep Vital Sign

NCT03018912
View directory record Official record
Conditions
Obstructive Sleep Apnea (OSA), Insomnia, Restless Leg Syndrome (RLS), Hypersomnia Type; Sleep Disorder, Shift Work Sleep Disorders
Interventions
Sleep VS
Other
Lead sponsor
Kaiser Permanente
Other
Eligibility
18 Years and older
Enrollment
1,260 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2019
U.S. locations
1
States / cities
Fontana, California
Source: ClinicalTrials.gov public record
Updated Jul 20, 2026 · Synced Sep 8, 2026, 11:51 AM EDT