Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.

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

Details

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

Criteria

Inclusion criteria:

• Provided written informed consent.

• Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.

• Have history of RLS symptoms at least 15 nights/month.

• Minimum average of 15 Periodic Limb Movements during Sleep per hour (measured using actigraphy).

Exclusion criteria:

• Secondary RLS

• Primary sleep disorder

• Sleep apnea

• Have any medical conditions that may impact efficacy assessments or that may present a safety concern.

• Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.

• Use of any prohibited medication.