At a glance
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A Randomized, Double Blind, Active- and Placebo-Controlled, Parallel Group Safety Study Assessing Simulated Driving Performance in XP13512-(GSK1838262) Treated Patients With Restless Legs Syndrome
In Brief
A Phase 2 clinical trial evaluating XP13512, Diphenhydramine, and 1 other intervention for Restless Legs Syndrome. Completed, enrolled 130 participants across 1 site.
Detailed Summary
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive a once daily dose of placebo (2 groups), XP13512 1200 mg, or XP13512 1800 mg for 16 days. On Day 16, one of the placebo groups also received one 50 mg dose of diphenhydramine (DPH) to assess the effects of an agent known to have sedative properties, while the other 3 groups received a DPH placebo.
Study Details
Timeline
Interventions
XP13512 once daily for 16 days
one 50 mg dose of diphenhydramine (DPH) on day 16
XP13512 placebo once daily for 16 days