Clinical trials: Idiopathic Restless Leg Syndrome
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 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS
This trial is a 6-week, double-blind, randomized, active and placebo-controlled parallel-group study with a primary objective of comparison of starting doses of pramipexole fixed-dose (0.25 mg daily) and pramipexole titrated-dose…
- Trial name
- NCT00375284
- Testing
- Pramipexole
- Where
- 52 sites in United States
- Volunteers
- 404 people
- Sponsor
- Boehringer Ingelheim
Idiopathic Restless Legs Syndrome
Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year in subjects who previously…
- Trial name
- NCT00498108
- Testing
- Rotigotine
- Where
- Germany
- Volunteers
- 341 people
- Sponsor
- UCB Pharma
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
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
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
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
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
Restless Legs Syndrome
A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS
The primary objective of this study is to investigate the effects on RLS symptoms and sleep disturbance of pramipexole (Mirapexin) 0.125 mg/day to 0.75 mg/day per os for 12 weeks, compared to placebo, in the treatment of patients…
- Trial name
- NCT00349531
- Testing
- Pramipexole
- Where
- 49 sites in Denmark, Finland and 7 more
- Volunteers
- 369 people
- Sponsor
- Boehringer Ingelheim
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
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
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
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
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
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
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
Restless Legs Syndrome
Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial.
- Trial name
- NCT00135993
- Testing
- Rotigotine
- Where
- United States
- Volunteers
- 811 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
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.