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A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Treating Tremor of Unknown Cause.

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ClinicalTrials.gov Identifier: NCT00236496
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : June 10, 2011
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to assess the safety and effectiveness of topiramate as compared to placebo in treating patients with tremor of unknown cause.

Condition or disease Intervention/treatment Phase
Essential Tremor Drug: topiramate Phase 3

Detailed Description:

Essential tremor is a very common form of tremor, occurring in up to 5% of people. It may be inherited. In 90% of patients, the tremor is in the hands; however, it can also be in the head, voice, legs, jaw, and tongue. Essential tremor may be treated by the blood pressure medicine propranolol or the anti-seizure drug primidone. The drawbacks of these drugs are that they tend to lose effectiveness over time, and they may cause side effects. Researchers believe that topiramate, an anti-seizure drug, may be effective in treating essential tremor. In this double blind, placebo-controlled study, patients with essential tremor will start at a low dose of topiramate (25 milligrams) or placebo. The dose will be gradually increased over 12 weeks to a maximum of 400 milligrams daily, taken in two divided doses. Then, each patient will stay on the established dose for the next 12 weeks. During the next phase of the study, the patients will slowly reduce the dose until they stop taking the study drug, after which, patients have the option of taking up to 600 milligrams of topiramate (not placebo) in a 14-week extension of the study. This study was designed to investigate the hypothesis that topiramate will be more effective than placebo in the treatment of essential tremor as measured by the Clinical Rating Scale for Tremor (TRS) and is well tolerated. The TRS is a three part scale that measures tremor location/severity rating, specific motor tasks/function rating, and functional disabilities resulting from tremor. Safety evaluations are assessed throughout the study.

Topiramate or placebo, starting with a dose of 25 mg, then gradually increased over 12 weeks up to 400 mg daily (two 100-mg tablets taken by mouth twice a day) and continued on this dose for 12 weeks in the maintenance phase; up to 600 milligrams of topiramate in the open-label phase.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in the Treatment of Essential Tremor
Study Start Date : October 2001
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor
Drug Information available for: Topiramate
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Clinical Rating Scale for Tremor (TRS) score at Visit 8 (or patient's final visit) of the double-blind phase

Secondary Outcome Measures :
  1. TRS subscale scores; composite normalized score; overall TRS score; patient and investigator assessment scores.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Current symptoms of essential tremor based on the Tremor Investigational Group (TRIG) criteria
  • Dominant upper extremity posture or action intention tremor of 2 (moderate) to 4 (severe)
  • In good health otherwise

Exclusion Criteria:

  • Patients with abnormal neurologic signs other than essential tremor
  • Taking more than one anti-tremor medication
  • Taking drugs known to cause tremors
  • With physical damage to the nervous system or Parkinson's disease
  • Known to be abusing drugs or alcohol
  • Women who are pregnant or breast-feeding
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00236496

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho-McNeil Neurologics, Inc.
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00236496     History of Changes
Other Study ID Numbers: CR002659
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: April 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
essential tremor

Additional relevant MeSH terms:
Essential Tremor
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents