Clinical trials: Idiopathic Restless Legs Syndrome
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
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
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.
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, 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 of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
The purpose of this study is to demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week maintenance period and to investigate the safety and…
- Trial name
- NCT03728933
- Testing
- Rotigotine 1 milligram/24 hours, Rotigotine 2 milligram/24 hours
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- UCB Biopharma SRL
Idiopathic Restless Legs Syndrome
Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.
- Trial name
- RLS (NCT00806026)
- Testing
- pramipexol, Pregabalin
- Where
- 110 sites in United States, Austria and 7 more
- Volunteers
- 731 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Idiopathic Restless Legs Syndrome
Study of SPM 962 in Patients With Restless Legs Syndrome (RLS)
The objective of this study is to evaluate the clinical efficacy and safety of SPM962 in patients with restless legs syndrome (RLS) with once-daily repeated doses of 4.5mg and 6.75mg during a 13-week dose-titration and…
- Trial name
- NCT01084551
- Testing
- SPM 962
- Where
- 8 sites in Japan
- Volunteers
- 284 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Restless Legs Syndrome
Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)
To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)
- Trial name
- NCT00654498
- Testing
- Pramipexole
- Where
- 16 sites in China
- Volunteers
- 306 people
- Sponsor
- Boehringer Ingelheim
Restless Legs Syndrome
Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome
Periodic Limb Movements (PLMs) during sleep in patients with Restless Legs Syndrome (RLS) have been shown to be associated with elevations in Blood Pressure (BP).
- Trial name
- ENCORE (NCT01455012)
- Testing
- Rotigotine
- Where
- 6 sites in Germany
- Volunteers
- 81 people
- Sponsor
- UCB BIOSCIENCES GmbH
Restless Legs Syndrome
Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome
This was a multicenter, open-label, dose-escalation, Phase 2A study with multiple administrations of the rotigotine transdermal system.
- Trial name
- NCT01495793
- Testing
- Rotigotine
- Where
- 12 sites in United States
- Volunteers
- 42 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Restless Legs Syndrome
Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)
The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome (RLS) in comparison to…
- Trial name
- NCT00472199
- Testing
- Pramipexole
- Where
- 42 sites in Austria, Belgium and 7 more
- Volunteers
- 331 people
- Sponsor
- Boehringer Ingelheim
Restless Legs Syndrome
Effect on RLS Symptom Severity After Switching to Neupro® in Patients Who Previously Experienced Augmentation
The objective is to assess the effect of Neupro® on the severity of Restless Leg Syndrome (RLS) symptoms and augmentation in patients with augmentation associated with previous oral dopaminergic therapy.
- Trial name
- AURORA (NCT01386944)
- Where
- 18 sites in Germany
- Volunteers
- 102 people
- Sponsor
- UCB Pharma