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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00311363 |
The primary objective of this trial is to assess the maintenance of efficacy of XP13512 taken once daily in the long-term treatment of patients suffering from Restless Legs Syndrome (RLS).
Condition | Intervention | Phase |
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Restless Legs Syndrome |
Drug: XP13512 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Long-Term Study of XP13512 Versus Placebo Treatment Assessing Maintenance of Efficacy and Safety in Patients With Restless Legs Syndrome |
Enrollment: | 327 |
Study Start Date: | April 2006 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
1200 mg XP13512
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Drug: XP13512
1200 mg XP13512, orally, once daily for 24 weeks followed by either 1200 mg XP13512 or placebo, orally, once daily for an additional 12 weeks
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2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo, orally, once daily for 12 weeks following single blind 24-week phase
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
XenoPort, Inc. Rise and Shine Clinical Trial Central Study Call Center | |
Santa Clara, California, United States, 95051 |
Study Director: | Pierre Tran, MD | XenoPort, Inc. |
Responsible Party: | XenoPort, Inc. ( Jay Huff, MD, VP of Clinical Development ) |
Study ID Numbers: | 111461 |
Study First Received: | April 3, 2006 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00311363 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Mental Disorders Restless Legs Syndrome Neurologic Manifestations Dyssomnias |
Sleep Disorders Psychomotor Agitation Neurobehavioral Manifestations Dyskinesias Sleep Disorders, Intrinsic |
Disease Nervous System Diseases Parasomnias Dyssomnias Sleep Disorders Psychomotor Agitation Dyskinesias Sleep Disorders, Intrinsic |
Signs and Symptoms Pathologic Processes Mental Disorders Syndrome Restless Legs Syndrome Psychomotor Disorders Neurologic Manifestations Neurobehavioral Manifestations |