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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00748098 |
The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.
Condition | Intervention | Phase |
---|---|---|
Restless Legs Syndrome (RLS) |
Drug: GSK1838262 Extended Release Tablets Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study |
Official Title: | Study RXP110908, a Polysomnography Study of GSK1838262 (XP13512) Extended Release Tablets Versus Placebo in the Treatment of Restless Legs Syndrome (RLS) and Associated Sleep Disturbance |
Estimated Enrollment: | 114 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
GSK1838262:placebo
GSK1838262 extended release tablets for Treatment Period 1 followed by Placebo for Treatment Period 2
|
Drug: GSK1838262 Extended Release Tablets
GSK1838262 extended release tablets
Drug: Placebo
Placebo
|
Placebo:GSK1838262
Placebo for Treatment Period 1 followed by GSK1838262 for Treatment Period 2
|
Drug: GSK1838262 Extended Release Tablets
GSK1838262 extended release tablets
Drug: Placebo
Placebo
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | RXP110908 |
Study First Received: | September 5, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00748098 |
Health Authority: | United States: Food and Drug Administration |
Restless Legs Syndrome RLS GSK1838262 XP13512 |
polysomnography PSG sleep disturbance gabapentin enacarbil |
Excitatory Amino Acids Ekbom syndrome Gabapentin Sleep Disorders Dyssomnias Psychomotor Agitation Dyskinesias |
Sleep Disorders, Intrinsic Signs and Symptoms Calcium, Dietary Mental Disorders Restless Legs Syndrome Neurologic Manifestations Neurobehavioral Manifestations |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Membrane Transport Modulators Pathologic Processes Sensory System Agents Therapeutic Uses Syndrome Psychomotor Disorders |
Analgesics Excitatory Amino Acid Antagonists Disease Tranquilizing Agents Parasomnias Nervous System Diseases Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |