Status:
COMPLETED
Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome
Lead Sponsor:
Neurocare
Collaborating Sponsors:
Ortho-McNeil Pharmaceutical
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This study is intended to determine whether topiramate is an efficacious and safe treatment for restless legs syndrome.
Detailed Description
Benzodiazepines, levo-dopa/carbidopa, dopamine agonists, anticonvulsants, and opioids have been used with variable success, to treat RLS. Often, RLS patients treated with a benzodiazepine, over the co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00200941
Start Date
August 1 2001
End Date
April 1 2005
Last Update
December 16 2005
Active Locations (1)
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1
Neurocare
Newton, Massachusetts, United States, 02459