A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Treating Tremor of Unknown Cause.
Primary Purpose
Essential Tremor
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
topiramate
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor focused on measuring tremor, essential tremor
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Clinical Rating Scale for Tremor (TRS) score at Visit 8 (or patient's final visit) of the double-blind phase
Secondary Outcome Measures
TRS subscale scores; composite normalized score; overall TRS score; patient and investigator assessment scores.
Full Information
NCT ID
NCT00236496
First Posted
October 7, 2005
Last Updated
June 8, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Ortho-McNeil Neurologics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00236496
Brief Title
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Treating Tremor of Unknown Cause.
Official Title
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in the Treatment of Essential Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Ortho-McNeil Neurologics, Inc.
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
tremor, essential tremor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
223 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
topiramate
Primary Outcome Measure Information:
Title
Clinical Rating Scale for Tremor (TRS) score at Visit 8 (or patient's final visit) of the double-blind phase
Secondary Outcome Measure Information:
Title
TRS subscale scores; composite normalized score; overall TRS score; patient and investigator assessment scores.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=485&filename=CR002659_CSR.pdf
Description
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in the Treatment of Essential Tremor
Learn more about this trial
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Treating Tremor of Unknown Cause.
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