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Restless Legs Syndrome

Part of Sleep Disorders, Intrinsic

6 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Restless Legs Syndrome

45 trials tracked for Restless Legs Syndrome: 17 in phase 3 or 4 and 1 with published results. The most-cited published study has 4 citations.

45Trials tracked

17Phase 3 & 4

0Recruiting

1With published results

Phase distribution

Phase 4 6 Phase 3 11 Phase 2 13 Other / NA 15

Phase 4 Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia Completed · 4 cited
Phase 4 Switching From Oral Dopamine Agonists to Rotigotine Completed
Phase 4 Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study Completed
Phase 4 Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome Completed
Phase 4 Long-term Study Of Ropinirole In Restless Legs Syndrome Completed
Phase 4 Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS) Completed

Show 39 more trials

Phase 3 Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome) Completed
Phase 3 Long-Term Study of Gabapentin Enacarbil (GEn, XP13512) vs. Placebo in Patients With Restless Legs Syndrome. Completed
Phase 3 Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS) Completed
Phase 3 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 Completed
Phase 3 XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome. Completed
Phase 3 Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance Completed
Phase 3 XP13512 vs. Placebo in Patients With Restless Legs Syndrome. Completed
Phase 3 Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance Completed
Phase 3 The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome Completed
Phase 3 Bupropion and Restless Legs Syndrome Completed
Phase 3 Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS) Completed
Phase 2 Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS) Completed
Phase 2 Simulated Driving Study in Restless Legs Syndrome Completed
Phase 2 Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist Completed
Phase 2 Iron Sucrose In The Treatment of Restless Legs Syndrome: Safety of Three Dose Regimens as Evaluated by Clinical Assessments Completed
Phase 2 Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome Completed
Phase 2 Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS) Completed
Phase 2 Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome Completed
Phase 2 Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms Completed
Phase 2 Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA) Completed
Phase 2 Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome Completed
Phase 2 Botulinum Toxin to Treat Restless Legs Syndrome Completed
Phase 2 Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients Completed
Phase 2 Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome Completed
N/A Non-interventional Observational Study on the Influence of Pramipexole on Sensory Symptoms of Restless Legs Syndrome (RLS) Completed
N/A Advancing Understanding of Transportation Options Completed
N/A A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome Completed
N/A Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD) Completed
N/A REQUIP RLS Post Marketing Surveillance Completed
N/A Spinal Cord Stimulation for Restless Legs Syndrome Completed
N/A Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome During Opioid Medication Reduction Completed
N/A Treatment of RLS/WED Symptoms Through Sensory Counter-stimulation Completed
N/A Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome Completed
N/A Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS Completed
N/A Noninvasive Peripheral Nerve Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study) Completed
N/A Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome Completed
N/A The Effect of Horizant (Gabapentin Enacarbil) on Augmentation Completed
N/A Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS Completed
N/A Effect on RLS Symptom Severity After Switching to Neupro® in Patients Who Previously Experienced Augmentation Completed

Showing the 45 most-cited and recently-updated of 45 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

Questions about Restless Legs Syndrome

Are there shared genetic factors for restless legs across different populations?

Research shows that restless legs syndrome (RLS) has both shared genetic factors across different populations and unique genetic markers specific to certain ancestries.

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Did a recent trial show active stimulation helps restless legs better than sham?

A 2024 trial found that active transcutaneous spinal cord stimulation reduced restless legs symptoms significantly more than a fake (sham) treatment over two weeks.

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Can transcutaneous spinal cord stimulation improve restless legs symptoms?

Yes, early research shows transcutaneous spinal cord stimulation (tsDCS) can significantly improve restless legs symptoms and sleep quality, but larger studies are needed.

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Does a machine learning model help diagnose restless legs in dialysis patients?

Yes, a machine learning model can help diagnose restless legs syndrome in dialysis patients, with one study reporting an AUC of 0.791.

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Can genetic ancestry affect my risk for restless legs syndrome?

Genetic ancestry does affect risk for restless legs syndrome, with specific risk genes found in African and Latin American populations that differ from those in European groups.

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See all 5 questions about Restless Legs Syndrome →