COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200941
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 16, 2005
Ortho-McNeil Pharmaceutical
Information provided by:

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

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: Topiramate Phase 4

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Educational/Counseling/Training
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)
Study Start Date : August 2001
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
Drug Information available for: Topiramate

Primary Outcome Measures :
  1. The average number of periodic leg movements during three consecutive nights of actigraphy beginning at the end of the double blind phase

Secondary Outcome Measures :
  1. Proportion of time in bed without leg movements during the three consecutive nights of actigraphy beginning at the end of the double blind phase
  2. SF-36 at the last visit of the double blind phase
  3. Score on the RLS Rating Scale (modified) questionnaire at the last visit of the double blind phase
  4. Periodic leg movements during sleep and wakefulness during the PSG recorded at the end of the double blind phase
  5. PSG measures including periodic leg movement arousal index, latency until sustained sleep, sleep efficacy, and wake after sleep onset
  6. Sleep diaries at the last double-blind visit
  7. Epworth sleepiness scale at the last double-blind visit

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00200941

Layout table for location information
United States, Massachusetts
Newton, Massachusetts, United States, 02459
Sponsors and Collaborators
Ortho-McNeil Pharmaceutical
Layout table for investigator information
Principal Investigator: Michael P Biber, MD Neurocare
Layout table for additonal information Identifier: NCT00200941    
Other Study ID Numbers: CAPSS-178
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 16, 2005
Last Verified: September 2005
Keywords provided by Neurocare:
Restless Legs Syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Hypoglycemic Agents
Physiological Effects of Drugs