Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Pharmaceutical
Information provided by:
Neurocare
ClinicalTrials.gov Identifier:
NCT00200941
First received: September 12, 2005
Last updated: December 15, 2005
Last verified: September 2005
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Neurocare:

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

Estimated Enrollment: 44
Study Start Date: August 2001
Estimated Study Completion Date: April 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200941

Locations
United States, Massachusetts
Neurocare
Newton, Massachusetts, United States, 02459
Sponsors and Collaborators
Neurocare
Ortho-McNeil Pharmaceutical
Investigators
Principal Investigator: Michael P Biber, MD Neurocare
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00200941     History of Changes
Other Study ID Numbers: CAPSS-178
Study First Received: September 12, 2005
Last Updated: December 15, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by Neurocare:
Restless Legs Syndrome
Topiramate
Actigraphy
Polysomnography

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on August 01, 2014