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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 |
Drug: Ropinirole Extended Release (XR) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00355641 History of Changes |
| Other Study ID Numbers: | 101468/206 |
| Study First Received: | July 20, 2006 |
| Last Updated: | March 10, 2011 |
| Health Authority: | Canada: Health Canada; United States: Food and Drug Administration |
|
Ropinirole Restless Legs Syndrome RLS |
|
Restless Legs Syndrome Psychomotor Agitation Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Parasomnias Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations |
Signs and Symptoms Ropinirole Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |