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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00256854 |
This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.
Condition | Intervention | Phase |
---|---|---|
Restless Legs Syndrome (RLS) |
Drug: ropinirole controlled-release for RLS |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 4-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting From Ropinirole Immediate Release (IR) to Ropinirole Extended Release (XR) Formulation in Patients With Restless Legs Syndrome (RLS) |
Estimated Enrollment: | 150 |
Study Start Date: | November 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: | ROX104805 |
Study First Received: | November 21, 2005 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00256854 |
Health Authority: | United States: Food and Drug Administration |
Ropinirole Restless Legs Syndrome RLS |
Ropinirole Ekbom syndrome Sleep Disorders Dyssomnias Psychomotor Agitation Dyskinesias Sleep Disorders, Intrinsic |
Signs and Symptoms Dopamine Mental Disorders Restless Legs Syndrome Neurologic Manifestations Neurobehavioral Manifestations |
Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Nervous System Diseases Parasomnias Antiparkinson Agents |
Dopamine Agonists Pharmacologic Actions Pathologic Processes Syndrome Therapeutic Uses Psychomotor Disorders Dopamine Agents Central Nervous System Agents |