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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00355641 |
Purpose
The primary objective of this study is to assess the safety and tolerability of ropinirole XR in the long-term treatment (up to 52 weeks)of adults with RLS.
| Condition | Intervention | Phase |
|---|---|---|
|
Restless Legs Syndrome (RLS) |
Drug: Ropinirole Extended Release (XR) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients With Restless Legs Syndrome (RLS) |
| Estimated Enrollment: | 450 |
| Study Start Date: | October 2005 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Subjects in North America ≥18 years of age who
Exclusion Criteria:
Subjects with a history of augmentation and/or end-of-dose rebound symptoms.
For subjects entering Study 206, certain medications must be discontinued prior to entering the study. The following medications are prohibited for the duration of the study period which is up to and including the Follow-up visit:
·dopamine agonists (including ropinirole immediate release formulation), dopamine antagonists (e.g., typical neuroleptics, metoclopramide), levodopa/carbidopa The minimum discontinuation period is generally 5 half-lives or 7 consecutive evening/nights medication-free, prior to baseline, whichever is the longer period. If the subject will require longer than 2 weeks following the Follow-up visit of the parent study to complete the washout, GSK must be consulted for further instructions.
The following exclusion criteria must be assessed at Study 206 Screen/Baseline for subjects who are not rolling in following completion of Study 101468/205 or ROX104805:
Contacts and Locations
Show 62 Study Locations| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 101468/206, SK&F-101468/206 |
| Study First Received: | July 20, 2006 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00355641 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
Restless Legs Syndrome RLS Ropinirole |
|
Ropinirole Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Sleep Disorders Antiparkinson Agents Psychomotor Agitation Dopamine Agonists Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Mental Disorders Syndrome |
Therapeutic Uses Restless Legs Syndrome Psychomotor Disorders Neurobehavioral Manifestations Disease Parasomnias Nervous System Diseases Dyssomnias Dyskinesias Pharmacologic Actions Neurologic Manifestations Dopamine Agents Central Nervous System Agents |