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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
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor focused on measuring tremor, essential tremor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 7, 2005
    Last Updated
    June 8, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    Ortho-McNeil Neurologics, Inc.
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    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

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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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