Long-Term Study of Gabapentin Enacarbil (GEn, XP13512) vs. Placebo in Patients With Restless Legs Syndrome.

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XenoPort, Inc.
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

Inclusion Criteria:

• Patients with primary RLS, based on the International RLS Study Group Diagnostic Criteria.

Exclusion Criteria:

• A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;

• Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's disease, Multiple Sclerosis, dyskinesias, and dystonias);

• Abnormal laboratory results, electrocardiogram (ECG) or physical findings;

• Pregnant or lactating women;

• Women of childbearing potential who are not practicing an acceptable method of birth control.