CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 581 enrolled
Drug / intervention
XP13512 (GEn)drug
Likely dose
XP13512 (GEn) 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/NCT00333359
NCT00333359Phase 3Completed
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An Open-Label, 52-Week Extension Study Assessing XP13512 Safety and Efficacy in Patients With Restless Legs Syndrome.

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

In Brief

A Phase 3 clinical trial evaluating XP13512 (GEn) for Restless Legs Syndrome. Completed, enrolled 581 participants.

Detailed 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).

Study Details

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

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 5, 2006
Enrollment StartJun 1, 2006
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.1 years ago

Interventions

XP13512 (GEn)drug

1200 mg XP13512, orally, once daily for 52 weeks