NCT00365352

XP13512 vs. Placebo in Patients With Restless Legs Syndrome.

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: XenoPort, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).

Detailed description

This was a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of XP13512 in subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive 1 of 3 once daily oral doses of XP13512 1200 mg, XP13512 600 mg, or placebo. The primary study objective was to compare the efficacy of XP13512 1200 mg taken once daily for 12 weeks versus placebo. The secondary study objectives were to assess the efficacy of XP13512 600 mg taken once daily for the reatment of RLS and to assess the onset of treatment benefits and improvement in sleep, pain, mood, quality of life, and safety and tolerability of both XP13512 1200 mg and 600 mg.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	XP13512 600MG	XP13512 600MG ONCE DAILY
DRUG	XP13512 1200MG	XP13512 1200MG ONCE DAILY
DRUG	PLACEBO	PLACEBO ONCE DAILY

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-08-17
• Last updated: 2013-07-22
• Results posted: 2011-05-11