CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 327 enrolled
Drug / intervention
GEn (XP13512) +2 moredrug
Likely dose
GEn (XP13512) 1200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00311363
NCT00311363Phase 3Completed
CompareCT.gov

A Long-Term Study of XP13512 Versus Placebo Treatment Assessing Maintenance of Efficacy and Safety in Patients With Restless Legs Syndrome.

XenoPort, Inc.·interventional·Posted Apr 5, 2006·Updated Jul 22, 2013

In Brief

A Phase 3 clinical trial evaluating GEn (XP13512) and Placebo for Restless Legs Syndrome. Completed, enrolled 327 participants.

Detailed Summary

The primary objective of this trial is to assess the maintenance of efficacy of gabapentin enacarbil (GEn, XP13512) taken once daily in the long-term treatment of patients suffering from Restless Legs Syndrome (RLS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 5, 2006
Enrollment StartApr 1, 2006
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 20.2 years ago

Interventions

GEn (XP13512)drug

1200 mg GEn (XP13512) orally, once daily for 24 weeks followed by either 1200 mg GEn (XP13512) or placebo, orally, once daily for an additional 12 weeks

GEn (XP13512)drug

1200 mg GEn (XP13512), orally, once daily for 24 weeks followed by either 1200 mg GEn (XP13512) or placebo, orally, once daily for an additional 12 weeks

Placebodrug

Placebo, orally, once daily for 12 weeks following single blind 24-week phase