Clinical trials: Idiopathic Restless Legs Syndrome
Restless Legs Syndrome
An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year.
- Trial name
- NCT00263068
- Testing
- Rotigotine
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- UCB Pharma
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
Dose Finding Study of Pramipexole (Sifrol) in Patients With Idiopathic Restless Legs Syndrome (RLS)
The purpose of this study was to evaluate the efficacy and safety of different doses of pramipexole (Sifrol) on subjective and objective symptoms of idiopathic Restless Legs Syndrome (RLS) and also to determine the optimal dose…
- Trial name
- NCT00239486
- Testing
- Pramipexole
- Where
- Finland
- Volunteers
- 109 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
Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)
The purpose of this study is to determine whether IPX159 is safe and effective in treating symptoms of RLS in subjects with Restless Legs Syndrome.
- Trial name
- NCT01521663
- Testing
- IPX159
- Where
- 38 sites in United States
- Volunteers
- 159 people
- Sponsor
- Impax Laboratories, LLC
Restless Legs Syndrome, Depression
Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances
The primary objective of this study is to determine the efficacy of pramipexole 0.125 mg to 0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and depressive symptoms, after 12 weeks of treatment
- Trial name
- NCT00356096
- Testing
- pramipexole
- Where
- 54 sites in Finland, France and 7 more
- Volunteers
- 404 people
- Sponsor
- Boehringer Ingelheim
Restless Legs Syndrome
Efficacy and Safety Study of Aplindore in Patients With Restless Legs Syndrome
This is a clinical trial to be conducted at multiple sites in the USA. Patients diagnosed with moderate to severe Restless Legs Syndrome will be randomly allocated to one of 5 treatment arms in the study.
- Trial name
- NCT00834327
- Where
- 24 sites in United States
- Volunteers
- 230 people
- Sponsor
- Neurogen Corporation
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 Leg Syndrome
Rotigotine Restless Legs Syndrome Dose Finding Trial
The objective of this trial is to demonstrate clinical efficacy of four different dosages of SPM 962 1.125 mg, 2.25 mg, 4.5 mg and 6.75 mg (corresponding to 2.5 cm2, 5 cm2, 10 cm2 and 15 cm2 patch size respectively) in RLS…
- Trial name
- NCT00243217
- Testing
- SPM 936
- Where
- Germany
- Volunteers
- 341 people
- Sponsor
- UCB Pharma
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
A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)
The primary objective is to assess sustained efficacy in patients who have responded to a 6 month treatment with open-label pramipexole.
- Trial name
- NCT00152958
- Testing
- Pramipexole
- Where
- 12 sites in Germany
- Volunteers
- 224 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
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 Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
The objective of this trial is to demonstrate that rotigotine (SPM 936) is effective in subjects with idiopathic RLS based on the PLMI (Periodic Limb Movements Index)(PLMs/total time in bed) as measured by polysomnography (PSG).
- Trial name
- NCT00275236
- Testing
- Rotigotine
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- UCB Pharma
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
Restless Legs Syndrome
Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)
A 12 week clinical trial was conducted in the United States in order to compare pramipexole (Mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in adult subjects.
- Trial name
- NCT00133198
- Testing
- Pramipexole
- Where
- 44 sites in United States
- Volunteers
- 345 people
- Sponsor
- Boehringer Ingelheim