15 completed, 2 not yet recruiting, 1 recruiting, 1 terminated. 5 Not applicable, 5 Phase 3, 4 Phase 4, 3 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 5 | Completed 4, Recruiting 1 |
| Phase 3 | 5 | Completed 5 |
| Phase 4 | 4 | Completed 4 |
| Phase 2 | 3 | Completed 1, Not yet recruiting 1, Terminated 1 |
| Phase 1 | 1 | Completed 1 |
Follow Restless Legs Syndrome (RLS): new trials by email Literature Review of Restless Legs Syndrome (RLS) trials Research Report on Restless Legs Syndrome (RLS)
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI Ferric Carboxymaltose Injection [Ferinject], Randomization, Questionnaire and Physical Exam - Restless Legs Syndrome (RLS) | Phase 2 | Not yet recruiting | University Hospital, Montpellier | 66 | 2026-10-01 | 2026-09-16 |
| Optimizing Extended-Duration (XD-) TOMAC Therapy for Restless Legs Syndrome (RLS) Investigational Extended Duration (XD-) TOMAC Therapy, Tonic Motor Activation (TOMAC) Therapy - Restless Legs Syndrome (RLS) | Not applicable | Recruiting | Noctrix Health, Inc. | 20 | 2026-06-08 | 2026-06-30 |
| EXPLORATORY STUDY OF THE POTENTIAL OF THERAPEUTIC EXERCISE IN THE TREATMENT OF WILLIS-EKBOM DISEASE Myofascial Self-Stretching Exercise Program, Buerger-Allen Exercise Program - Willis-Ekbom Disease, Restless Legs Syndrome (RLS) | Not applicable | Completed | Universidad Pontificia Comillas | 27 | 2026-03-03 | 2026-09-09 |
| Study on the Mechanism of Gut Microbiota Mediating Restless Legs Syndrome Through Iron Metabolism Not applicable- observational study - Restless Legs Syndrome (RLS) | Not yet recruiting | Wenxia Jiang | 100 | 2025-12-15 | 2026-01-02 | |
| Effect of Intra-Dialytic Muscle Energy Technique on Restless Leg Syndrome in Hemodialysis Patients Muscle Energy Technique, Routine Medical Treatment and Hemodialysis - Restless Legs Syndrome (RLS), End-Stage Renal Disease | Not applicable | Completed | Cairo University | 60 | 2025-08-01 | 2026-08-05 |
| Effectiveness of Matrix Rhythm Therapy for Restless Legs Syndrome MATRİX RHYTHM THERAPY, HOME EXERCISE PROGRAM - Restless Legs Syndrome (RLS) | Not applicable | Completed | Pamukkale University | 28 | 2021-05-04 | 2026-05-01 |
| Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia Injectafer® (Ferric Carboxymaltose - FCM), Placebo (Normal Saline) - Restless Legs Syndrome (RLS) | Phase 2 | Terminated | American Regent, Inc. | 70 | 2017-07-10 | 2025-04-11 |
| A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients Placebo, Gabapentin enacarbil - Restless Legs Syndrome (RLS) | Phase 4 | Completed | Astellas Pharma Inc | 375 | 2017-03-30 | 2024-12-12 |
| Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS Injectafer, Placebo - Restless Legs Syndrome (RLS) | Phase 3 | Completed | American Regent, Inc. | 209 | 2015-01-01 | 2021-10-12 |
| Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment Gabapentin enacarbil - Restless Legs Syndrome (RLS) | Phase 4 | Completed | Astellas Pharma Inc | 19 | 2013-11-05 | 2024-11-08 |
| Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome Rotigotine, Placebo patchs - Restless Legs Syndrome (RLS) | Phase 4 | Completed | University Hospital, Montpellier | 130 | 2012-11-26 | 2018-05-15 |
| Efficacy of Tyrosine in Restless Legs Syndrome L-Tyrosine - Restless Legs Syndrome (RLS) | Not applicable | Completed | Seton Healthcare Family | 5 | 2012-01-01 | 2017-04-27 |
| Study to Assess the Effect of Gabapentin Enacarbil on Simulated Driving in Healthy Subjects gabapentin enacarbil, diphenhydramine, placebo - Restless Legs Syndrome (RLS) | Phase 1 | Completed | XenoPort, Inc. | 36 | 2011-06-01 | 2013-07-16 |
| Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance GSK1838262 Extended Release Tablets, Placebo - Restless Legs Syndrome, Restless Legs Syndrome (RLS) | Phase 3 | Completed | XenoPort, Inc. | 136 | 2008-10-01 | 2013-07-22 |
| 12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome ropinirole CR-RLS - Restless Legs Syndrome (RLS), Restless Legs Syndrome | Phase 4 | Completed | GlaxoSmithKline | 39 | 2006-10-01 | 2016-10-28 |
| Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS) Ferric Carboxymaltose (FCM), Placebo - Restless Legs Syndrome (RLS) | Phase 2 | Completed | American Regent, Inc. | 45 | 2006-03-01 | 2018-02-20 |
| RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole ropinirole Extended Release (XR) - Restless Legs Syndrome, Restless Legs Syndrome (RLS) | Phase 3 | Completed | GlaxoSmithKline | 568 | 2006-02-01 | 2016-10-18 |
| Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome) Ropinirole IR 1 mg, Ropinirole IR 2 mg, Ropinirole IR 1 mg Placebo - Restless Legs Syndrome, Restless Legs Syndrome (RLS) | Phase 3 | Completed | GlaxoSmithKline | 135 | 2005-11-14 | 2019-03-15 |
| A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome Ropinirole - Restless Legs Syndrome (RLS), Restless Legs Syndrome | Phase 3 | Completed | GlaxoSmithKline | 360 | 2003-08-01 | 2016-10-17 |
Restless Legs Syndrome (19) · Cardiovascular Diseases (1) · Fatigue (1) · Kidney Failure, Chronic (1) · Parasomnias (1) · Sleep Wake Disorders (1)
Dyssomnias (19) · Mental Disorders (19) · Nervous System Diseases (19) · Sleep Disorders, Intrinsic (19) · Parasomnias (18) · Sleep Wake Disorders (18) · Pathological Conditions, Signs and Symptoms (2) · Chronic Disease (1) · Disease Attributes (1) · Female Urogenital Diseases (1) · Female Urogenital Diseases and Pregnancy Complications (1) · Kidney Diseases (1) · Male Urogenital Diseases (1) · Neurologic Manifestations (1) · Pathologic Processes (1)
1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid (4) · ferric carboxymaltose (4) · Saline Solution (2) · ropinirole (2) · Diphenhydramine (1) · Random Allocation (1) · Renal Dialysis (1) · Restraint, Physical (1) · Spinal Puncture (1) · Surveys and Questionnaires (1) · Therapeutics (1) · Tyrosine (1) · rotigotine (1)
GlaxoSmithKline (4) · American Regent, Inc. (3) · Astellas Pharma Inc (2) · University Hospital, Montpellier (2) · XenoPort, Inc. (2) · Cairo University (1) · Noctrix Health, Inc. (1) · Pamukkale University (1) · Seton Healthcare Family (1) · Universidad Pontificia Comillas (1) · Wenxia Jiang (1)
United States (10) · France (3) · Japan (2) · Spain (2) · Australia (1) · Austria (1) · Belgium (1) · Denmark (1) · Egypt (1) · Germany (1) · Italy (1) · Netherlands (1) · Norway (1) · Sweden (1) · Turkey (Türkiye) (1)
Jonathan D Charlesworth, PhD (1) · Khaled Khechen, MD (1) · Laura Lillo Triguero, MD (1) · Mark Falone, MD (1) · Yves Dauvilliers, PU PH (1)