Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is intended to determine whether topiramate is an efficacious and safe treatment for restless legs syndrome.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Neurocare
• Collaborator: Ortho-McNeil Pharmaceutical
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• The symptoms of each subject must meet the diagnostic criteria of the International RLS Study Group

• More than five periodic leg movements per hour recorded during baseline polysomnography (PSG)

• Each subject must discontinue all treatments for RLS and agreed not to take other RLS treatments during the study

Exclusion Criteria:

• Clinically unstable medical problems

• History of nephrolithiasis

• Progressive neurologic disease

• Inadequate therapeutic response from two previous treatment regimens for RLS

• Subjects unable to discontinue medications known to cause or suppress RLS

• Subjects with sleep apnea syndrome

• Subjects consuming daily more than three beverages containing caffeine