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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00197080 |
The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).
Condition | Intervention | Phase |
---|---|---|
Restless Legs Syndrome (RLS) |
Drug: Ropinirole Extended Release (XR) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients With Restless Legs Syndrome |
Estimated Enrollment: | 380 |
Study Start Date: | June 2005 |
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 101468/205, SK&F-101468/205 |
Study First Received: | September 13, 2005 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00197080 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; United States: Food and Drug Administration |
Restless Legs Syndrome RLS |
Neurotransmitter Agents Ropinirole Sleep Disorders Dyssomnias Psychomotor Agitation Dopamine Agonists Dyskinesias Sleep Disorders, Intrinsic |
Signs and Symptoms Dopamine Mental Disorders Restless Legs Syndrome Neurologic Manifestations Dopamine Agents Neurobehavioral Manifestations |
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 |