Clinical trials: Restless Leg Syndrome (RLS)
Restless Legs Syndrome
Non-interventional Observational Study of Pramipexole in Restless Legs Syndrome: Impact on Quality of Life
In this German non-interventional observational study 1980 patients diagnosed with Restless Legs Syndrome (RLS) will be investigated by 990 General Practitioners across all federal states in Germany.
- Trial name
- NCT00539461
- Where
- 317 sites in Germany
- Volunteers
- 2,023 people
- Sponsor
- Boehringer Ingelheim
Restless Legs Syndrome
Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome
The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless leg syndrome (RLS).
- Trial name
- NCT00136045
- Testing
- Rotigotine
- Where
- Germany
- Volunteers
- 549 people
- Sponsor
- UCB Pharma
RLS
A PK and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLS
The primary objective is to assess the pharmacokinetics (PK) of gabapentin following the single-dose administration of HORIZANT (Gabapentin Enacarbil) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe…
- Trial name
- RLS (NCT02633657)
- Testing
- HORIZANT 300 mg
- Where
- 4 sites in United States
- Sponsor
- XenoPort, Inc.
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
Specified Drug Use-Results Survey of Regnite
This study is to investigate the long-term safety and efficacy and the information on the proper use of Regnite® under conditions of daily clinical use.
- Trial name
- NCT01887613
- Testing
- Regnite
- Where
- 7 sites in Japan
- Volunteers
- 1,597 people
- Sponsor
- Astellas Pharma Inc
Restless Legs Syndrome
Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome
The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).
- Trial name
- NCT00197080
- Testing
- Ropinirole Extended Release (XR)
- Where
- 70 sites in United States, Canada
- Volunteers
- 380 people
- Sponsor
- GlaxoSmithKline
Restless Leg Syndrome (RLS)
Observe Change in Nasal Swab DRD2 Gene Expression in Restless Legs Syndrome (RLS) Patients on Prolonged Dopamine Agonist Treatment
The study aims to observe changes in dopaminergic genes expression in peripheral tissue upon prolonged dopamine agonist treatment on patients with Restless Legs Syndrome (RLS).
- Trial name
- RLS-DRD2gene (NCT06726785)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- HBC Immunology Inc
Restless Legs Syndrome (RLS)
Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment
To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to severe primary RLS patients with moderate renal impairment and to confirm dosage and administration in such population.
- Trial name
- NCT01981941
- Testing
- Gabapentin enacarbil
- Where
- 5 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Astellas Pharma 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
Restless Legs Syndrome
Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food
This study in RLS patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat…
- Trial name
- NCT00419692
- Testing
- Ropinirole
- Where
- 2 sites in Germany, South Africa
- Volunteers
- 32 people
- Sponsor
- GlaxoSmithKline
Restless Legs Syndrome
XP13512 (GSK1838262) Versus 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
- NCT00298623
- Testing
- XP13512 (GSK1838262)
- Volunteers
- 222 people
- Sponsor
- XenoPort, 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
Restless Legs Syndrome
Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
This is a multi-center, open-label extension trial conducted at the same European sites that participated in trial SP 709 (NCT00243217).
- Trial name
- NCT00498186
- Testing
- Rotigotine
- Where
- 24 sites in Austria, Germany and 1 more
- Volunteers
- 295 people
- Sponsor
- UCB Pharma
Restless Legs Syndrome (RLS)
Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS
This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5.
- Trial name
- NCT02397057
- Testing
- Injectafer
- Where
- 19 sites in United States
- Volunteers
- 209 people
- Sponsor
- American Regent, Inc.
Restless Legs Syndrome, Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)
The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome
Ropinirole has shown to improve mood in depressed patients as well as to improve the symptoms of Restless Legs Syndrome. Up to 40% of RLS patients suffer from mild depression, therefore it would be important for decisions no…
- Trial name
- NCT00357097
- Testing
- Ropinirole
- Where
- 50 sites in Germany
- Volunteers
- 240 people
- Sponsor
- GlaxoSmithKline
Restless Legs Syndrome
A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS
The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.
- Trial name
- NCT00625547
- Testing
- cabergoline, levodopa
- Where
- 50 sites in Austria, Germany and 2 more
- Volunteers
- 361 people
- Sponsor
- Pfizer
Restless Legs Syndrome
Clinical Evaluation of Ropinirole IR (Immediate Release) Tablets in Patients Who Are Diagnosed With Symptomatic Restless Legs Syndrome (RLS) Associated With Chronic Kidney Disease (CKD) Managed With Haemodialysis (Including Haemofiltration and Haemodiafiltration)
This is a multicenter, placebo controlled, parallel group, double-blind, randomized comparison study to evaluate the efficacy and safety of ropinirole IR tablets orally administered for 12 weeks in patients with symptomatic…
- Trial name
- NCT00996944
- Testing
- Ropinirole immediate release (IR)
- Where
- 19 sites in Japan
- Volunteers
- 34 people
- Sponsor
- GlaxoSmithKline