NCT01332318

Simulated Driving Study in Restless Legs Syndrome

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: XenoPort, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study was a multicenter, randomized, double blind, active and placebo controlled, parallel group study. Eligible subjects were randomized in a 1:1:1:1 ratio to 1 of the following 4 treatment groups: A) XP13512 Placebo + Diphenhydramine Placebo (Pbo) B) XP13512 1200 mg/day + Diphenhydramine Placebo (1200 mg) C) XP13512 1800 mg/day + Diphenhydramine Placebo (1800 mg) D) XP13512 Placebo + 50 mg Diphenhydramine (Pbo/DPH)

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	XP13512	XP13512 once daily for 16 days
DRUG	Diphenhydramine	one 50 mg dose of diphenhydramine (DPH) on day 16
DRUG	Placebo	XP13512 placebo once daily for 16 days

Timeline

• Start date: 2007-04-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2011-04-11
• Last updated: 2013-07-26
• Results posted: 2011-06-28

Locations

1 site across 1 country: United States