NCT00333359

XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome.

An Open-Label, 52-Week Extension Study Assessing XP13512 Safety and Efficacy in Patients With Restless Legs Syndrome.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 581 (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 long-term safety and efficacy of XP13512 (Gabapentin Enacarbil) taken once daily for the treatment of patients suffering from Restless Legs Syndrome (RLS).

Detailed description

Study XP055 is a multicenter, open-label, 52-week extension study of XP13512 (Gabapentin Enacarbil \[GEn\]) given once daily to eligible subjects with Restless Legs Syndrome (RLS) who had previously completed 1 of the following studies and met eligibility criteria: XP052 (110963 \[NCT00298623\]), XP053 (111460 \[NCT00365352\]), XP081 (111462 \[NCT01332305\]), and XP083 (111463 \[NCT01332318\]).

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	XP13512 (GEn)	1200 mg XP13512, orally, once daily for 52 weeks

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-06-05
• Last updated: 2013-07-22
• Results posted: 2011-06-23