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Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome

NCT ID: NCT00200941

Last Updated: 2005-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2005-04-30

Brief Summary

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

Detailed Description

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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 course of several months, develop tolerance to the medication. Also, benzodiazepines can cause confusion or daytime sleepiness and may be addictive. Patients may also develop tolerance to levo-dopa/carbidopa treatment. Because of the short half-life, symptoms may be suppressed for only the first part of the sleep period and then recur later during the night. Rebound has been reported. Worse yet, augmentation, the occurrence of RLS symptoms, often more severe than before treatment began, earlier in the day, may occur in up to 80% of RLS patients treated with levod-dopa/carbidopa. Dopamine agonists, including pergolide, pramipexole, and ropinirole, are effective for some patients but not for others. Common side effects of these drugs include coryza, hypotension, and rash. Of the anticonvulsants, preliminary reports suggest that gabapentin, carbamazepine, and divalproex can suppress RLS symptoms in some patients, especially those with mild RLS. Side effects include sleepiness, ataxia, and weight gain. Opioid treatment for RLS has been described as effective but, aside from the stigma of taking controlled substances regularly, side effects may include nausea, sedation, constipation, and dysequilibrium. Iron supplementation is therapeutic in some patients with iron deficiency and RLS.

Preliminary anecdotal data suggest that topiramate reduces RLS symptoms. Topiramate has several potential mechanisms of action including enhancement of GABA-mediated inhibition, which may account for the observed benefit in patients with RLS.

Topiramate may be a better alternative than the currently available treatments to suppress RLS symptoms. Like gabapentin, it offers the possibility of decreasing RLS symptoms while also diminishing pain, especially in those patients who have limb pain from neuropathy, radiculopathy, or other causes. Unlike gabapentin, topiramate may help overweight patients with RLS lose weight, if anedotal reports on weight reduction with the medication are correct.

Conditions

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Restless Legs Syndrome

Keywords

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Restless Legs Syndrome Topiramate Actigraphy Polysomnography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

DOUBLE

Interventions

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Topiramate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ortho-McNeil Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Neurocare

OTHER

Sponsor Role lead

Principal Investigators

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Michael P Biber, MD

Role: PRINCIPAL_INVESTIGATOR

Neurocare

Locations

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Neurocare

Newton, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CAPSS-178

Identifier Type: -

Identifier Source: org_study_id