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Sponsors and Collaborators: |
Neurocare Ortho-McNeil Pharmaceutical |
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Information provided by: | Neurocare |
ClinicalTrials.gov Identifier: | NCT00200941 |
This study is intended to determine whether topiramate is an efficacious and safe treatment for restless legs syndrome.
Condition | Intervention | Phase |
---|---|---|
Restless Legs Syndrome |
Drug: Topiramate |
Phase IV |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Effacy and Safety of Topiramate in Subjects With Restless Legs Syndrome (RLS) |
Estimated Enrollment: | 44 |
Study Start Date: | August 2001 |
Estimated Study Completion Date: | April 2005 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Neurocare | |
Newton, Massachusetts, United States, 02459 |
Principal Investigator: | Michael P Biber, MD | Neurocare |
Study ID Numbers: | CAPSS-178 |
Study First Received: | September 12, 2005 |
Last Updated: | December 15, 2005 |
ClinicalTrials.gov Identifier: | NCT00200941 History of Changes |
Health Authority: | United States: Institutional Review Board |
Restless Legs Syndrome Topiramate Actigraphy Polysomnography |
Sleep Disorders Dyssomnias Psychomotor Agitation Dyskinesias Neuroprotective Agents Sleep Disorders, Intrinsic Anti-Obesity Agents |
Signs and Symptoms Mental Disorders Restless Legs Syndrome Neurologic Manifestations Topiramate Neurobehavioral Manifestations Anticonvulsants |
Physiological Effects of Drugs Sleep Disorders Psychomotor Agitation Neuroprotective Agents Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Mental Disorders Syndrome Therapeutic Uses Restless Legs Syndrome Psychomotor Disorders Topiramate |
Neurobehavioral Manifestations Disease Parasomnias Nervous System Diseases Dyssomnias Dyskinesias Protective Agents Pharmacologic Actions Anti-Obesity Agents Neurologic Manifestations Central Nervous System Agents Anticonvulsants |