Clinical trials: Restless Legs Syndrome (RLS)
- Condition Restless Legs Syndrome (RLS)
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
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
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
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
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.
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.
Restless Legs Syndrome
Non-interventional Observational Study on the Influence of Pramipexole on Sensory Symptoms of Restless Legs Syndrome (RLS)
The main goal of this open-label, prospective, non-controlled, non-interventional post marketing surveillance study is to evaluate how pramipexole treatment works when applied in actual practice.
- Trial name
- NCT00887289
- Where
- 784 sites in Germany
- Volunteers
- 1,504 people
- Sponsor
- Boehringer Ingelheim
Restless Legs Syndrome, Restless Legs Syndrome (RLS)
Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)
This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.
- Trial name
- NCT00256854
- Testing
- Ropinirole IR 1 mg, Ropinirole IR 2 mg, Ropinirole CR 2 mg
- Where
- 30 sites in United States
- Volunteers
- 135 people
- Sponsor
- GlaxoSmithKline
Restless Legs Syndrome
Noninvasive Peripheral Nerve Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study)
Multi-center, prospective double-blind randomized controlled pivotal study of noninvasive peripheral nerve stimulation (NPNS) with the NTX100 Neuromodulation System for patients with medication-refractory moderate-severe primary…
- Trial name
- NCT04874155
- Testing
- NTX100 Neuromodulation System - Active, NTX100 Neuromodulation System - Open-Label
- Where
- 7 sites in United States
- Volunteers
- 133 people
- Sponsor
- Noctrix Health, Inc.
Restless Legs Syndrome (RLS)
A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
The objective of this study was to assess the efficacy of once-daily oral administration of gabapentin enacarbil versus placebo, based on the change in International Restless Legs Syndrome Rating Scale (IRLS) score in…
- Trial name
- NCT03053427
- Testing
- Gabapentin enacarbil
- Where
- 46 sites in Japan
- Volunteers
- 375 people
- Sponsor
- Astellas Pharma Inc
Idiopathic Restless Legs Syndrome
Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise
This non-interventional observational study is designed to gain data for Neupro® in restless legs syndrome (RLS) under real life conditions in line with the summary of product characteristics (SmPC) related to effectiveness…
- Trial name
- RLS-Practise (NCT01113710)
- Testing
- Neupro®
- Where
- 80 sites in Germany
- Volunteers
- 687 people
- Sponsor
- UCB Pharma