Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome

Completed · Phase 4

Conditions studied: Restless Legs Syndrome

In brief

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

Key facts

Study ID

NCT00200941

Run by

Neurocare

People needed

44

Starts

2001-08-01

Expected to finish

2005-04-01

Last updated by the study team

2005-12-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Neurocare — Newton, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.