Clinical trials: Restless Legs Syndrome (RLS)
Idiopathic Restless Legs Syndrome
A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.
The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS.
- Trial name
- NCT00390689
- Testing
- Pramipexole 0.125 mg tablet, Pramipexole 0.5 mg tablet
- Where
- 34 sites in Japan
- Volunteers
- 154 people
- Sponsor
- Boehringer Ingelheim
Restless Legs Syndrome
Simulated Driving Study in Restless Legs Syndrome
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS).
- Trial name
- XP083 (NCT01332318)
- Testing
- XP13512, Diphenhydramine
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome, Ekbom Syndrome
Switching From Oral Dopamine Agonists to Rotigotine
The primary objective is to demonstrate safety and tolerability of switching patients with Restless Legs Syndrome (RLS) from an oral dopamine agonist to rotigotine.
- Conditions
- Restless Legs Syndrome, Ekbom Syndrome, Willis-Ekbom Disease
- Trial name
- SWITCH (NCT01976871)
- Testing
- Rotigotine
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- John Winkelman, MD, PhD
Restless Leg Syndrome
Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome.
The purpose of this research study is to compare the safety and effectiveness of local injections of botulinum toxin A (Xeomin®) to an inactive test substance (placebo) in a medical condition called Restless Leg Syndrome.
- Trial name
- NCT01931878
- Testing
- incobotulinumtoxinA
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Yale University
Restless Legs Syndrome
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.
- Trial name
- NCT00991276
- Testing
- pregabalin, pramipexole
- Where
- 41 sites in United States
- Volunteers
- 85 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Restless Legs Syndrome
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)
Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS
- Trial name
- NCT02231918
- Testing
- MIRAPEX® - low, MIRAPEX® - medium, MIRAPEX® - high
- Volunteers
- 26 people
- Sponsor
- Boehringer Ingelheim
Restless Legs Syndrome
XP13512 vs. Placebo in Patients With Restless Legs Syndrome.
The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).
- Trial name
- NCT00365352
- Testing
- XP13512 600MG, XP13512 1200MG
- Volunteers
- 325 people
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome
Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical…
- Trial name
- NCT00721279
- Testing
- Sifrol® (pramipexole dihydrochloride)
- Where
- 127 sites in Austria
- Volunteers
- 549 people
- Sponsor
- Boehringer Ingelheim
Restless Legs Syndrome
Long-Term Study of Gabapentin Enacarbil (GEn, XP13512) vs. Placebo in Patients With Restless Legs Syndrome.
The primary objective of this trial is to assess the maintenance of efficacy of gabapentin enacarbil (GEn, XP13512) taken once daily in the long-term treatment of patients suffering from Restless Legs Syndrome (RLS).
- Trial name
- NCT00311363
- Testing
- GEn (XP13512)
- Volunteers
- 327 people
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome
Long-term Study Of Ropinirole In Restless Legs Syndrome
This is an initial placebo-controlled study followed by open treatment evaluating the effectiveness and tolerability of ropinirole long-term in patients with moderate to severe Restless Legs Syndrome.
- Trial name
- NCT00329602
- Testing
- Ropinirole
- Where
- 39 sites in Australia, Czechia and 9 more
- Volunteers
- 404 people
- Sponsor
- GlaxoSmithKline
Restless Legs Syndrome, End-Stage Renal Disease
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
This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.
- Trial name
- NCT01537042
- Testing
- Rotigotine
- Where
- 15 sites in United States, Austria and 4 more
- Volunteers
- 30 people
- Sponsor
- UCB BIOSCIENCES GmbH
Restless Legs Syndrome, Neuropathic Pain
Spinal Cord Stimulation for Restless Legs Syndrome
The overall goal of this proposed study is to evaluate the underlying mechanisms of neural control of blood flow in the lower extremities in humans with restless leg syndrome (RLS).
- Trial name
- NCT03539081
- Testing
- Dual-energy X-ray absorptiometry Scan, Laboratory Measurements, Blood Flow Measurement
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Marshall Holland
Restless Legs Syndrome
Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome During Opioid Medication Reduction
Prospective open-label single-arm feasibility study assessing the tolerability of opioid medication reduction in conjunction with noninvasive peripheral nerve stimulation (NPNS) for patients taking prescription opioids to treat…
- Trial name
- NCT04698343
- Testing
- Noninvasive Peripheral Nerve Stimulation (NPNS)
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Noctrix Health, Inc.
Restless Legs Syndrome
Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms
The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.
- Trial name
- NCT00389831
- Testing
- Rotigotine Nasal Spray
- Where
- Germany
- Volunteers
- 44 people
- Sponsor
- UCB Pharma
Restless Legs Syndrome
Botulinum Toxin to Treat Restless Legs Syndrome
This study will test whether botulinum toxin (Botox) may relieve the uncomfortable sensations patients with restless legs syndrome (RLS) experience.
- Trial name
- NCT00479154
- Testing
- Botulinum Toxin A
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Restless Legs Syndrome
Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS)
The purpose of the study is to show that Rotigotine improves Restless Legs Syndrome (RLS) symptoms in subjects with moderate to severe RLS during both day and evening.
- Trial name
- RESTORE (NCT01569464)
- Testing
- Rotigotine
- Where
- 18 sites in United States
- Volunteers
- 150 people
- Sponsor
- UCB Pharma
Idiopathic Restless Legs Syndrome
A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients
The primary objective of this study is to investigate efficacy and safety of SPM 962 in Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group comparative study following once-daily multiple…
- Trial name
- NCT00666965
- Testing
- SPM 962
- Where
- 8 sites in Japan
- Volunteers
- 230 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Restless Legs Syndrome
Bupropion and Restless Legs Syndrome
The purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (RLS).
- Trial name
- NCT00621517
- Testing
- Bupropion
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- East Tennessee State University
Idiopathic Restless Legs Syndrome
A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome
The aims of the trial are to assess the safety and the efficacy of SPM 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese patients with restless legs syndrome (RLS) in a…
- Trial name
- RLS (NCT01562743)
- Testing
- SPM 962
- Volunteers
- 185 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Restless Legs Syndrome
Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study
Gabapentin enacarbil (GEn; GSK1838262; HORIZANT), at a dose of 600 mg/day, is currently approved in the United States for the treatment of adults with moderate-to-severe primary Restless Legs Syndrome (RLS).
- Trial name
- CONCORD (NCT01668667)
- Testing
- GSK1838262 600 mg, GSK1838262 450 mg, GSK1838262 300 mg
- Where
- 42 sites in United States
- Volunteers
- 501 people
- Sponsor
- XenoPort, Inc.