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A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine

Primary Purpose

Migraine, Common Migraine, Classic Migraine

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 Migraine focused on measuring Migraine, Common Migraine, Classic Migraine, Headache, Topiramate, Prophylaxis, Prevention

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 6 months prior to the study Between 3 to 12 migraine periods and no greater than 15 headache days (migraine and non-migraine) per month during the Baseline Phase No clinically significant abnormalities on neurological exams, electrocardiogram (ECG) or clinical laboratory test results at baseline Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test) Exclusion Criteria: Patients with headaches other than migraine Patients with episodic tension or sinus headaches Onset of migraine after age of 50 years Patients who have failed more than two adequate regimens for migraine prophylaxis Patients who overuse pain medications or certain other medications

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change in monthly (28 day) migraine period rate from the prospective baseline period to the double-blind phase.

    Secondary Outcome Measures

    Proportion of patients responding to the treatment. Changes from baseline to the double-blind phase in number of monthly migraine attacks, monthly migraine days, number of days/month requiring rescue medication and Health-Related Quality of Life measures

    Full Information

    First Posted
    September 30, 2005
    Last Updated
    November 18, 2010
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00231595
    Brief Title
    A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate the Efficacy and Safety of Topiramate in the Prophylaxis of Migraine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2002 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and efficacy of three doses of topiramate (50 milligrams[mg], 100mg, and 200mg per day) compared with placebo in the prevention of migraine. The study will also assess the dose response relationship and the efficacy of treatment with topiramate versus placebo on Health-Related Quality of Life.
    Detailed Description
    This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the efficacy and safety of three different doses of topiramate (50mg, 100mg, and 200mg daily) in migraine prophylaxis. The study consists of five phases: Baseline (determination of whether patients meet the eligibility criteria and tapering of any migraine medication patients are already taking), Double-Blind (patients receive either 50 milligrams[mg], 100mg, 200mg of topiramate, or placebo), Blinded Transition Phase (doses of study medication are adjusted over 7 weeks in preparation for the Open-Label Extension Phase), Open-Label Extension Phase (patients continue the study medication in open-label manner for up to 6 months; doses are adjusted to maximize effectiveness and minimize side effects), Taper/Exit Phase (study medication is slowly discontinued over 2 weeks). The primary study hypothesis is that one or more of the three doses of topiramate (50, 100, 200 mg/day) will be superior to placebo in the prophylaxis of migraine based on the change in monthly (28 day) migraine period rate from the Prospective Baseline Period to the Double-Blind Phase. Topiramate tablets (50milligrams [mg], 100mg, 200mg, or placebo) taken by mouth as twice-daily regimen during the 26-week Double-Blind Phase. Doses are adjusted and continued during the 6 month Open-Label Extension Phase after which they are tapered over 2 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine, Common Migraine, Classic Migraine, Headache
    Keywords
    Migraine, Common Migraine, Classic Migraine, Headache, Topiramate, Prophylaxis, Prevention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    768 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    topiramate
    Primary Outcome Measure Information:
    Title
    Change in monthly (28 day) migraine period rate from the prospective baseline period to the double-blind phase.
    Secondary Outcome Measure Information:
    Title
    Proportion of patients responding to the treatment. Changes from baseline to the double-blind phase in number of monthly migraine attacks, monthly migraine days, number of days/month requiring rescue medication and Health-Related Quality of Life measures

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 6 months prior to the study Between 3 to 12 migraine periods and no greater than 15 headache days (migraine and non-migraine) per month during the Baseline Phase No clinically significant abnormalities on neurological exams, electrocardiogram (ECG) or clinical laboratory test results at baseline Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test) Exclusion Criteria: Patients with headaches other than migraine Patients with episodic tension or sinus headaches Onset of migraine after age of 50 years Patients who have failed more than two adequate regimens for migraine prophylaxis Patients who overuse pain medications or certain other medications
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & 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

    Citations:
    PubMed Identifier
    14982912
    Citation
    Brandes JL, Saper JR, Diamond M, Couch JR, Lewis DW, Schmitt J, Neto W, Schwabe S, Jacobs D; MIGR-002 Study Group. Topiramate for migraine prevention: a randomized controlled trial. JAMA. 2004 Feb 25;291(8):965-73. doi: 10.1001/jama.291.8.965.
    Results Reference
    result

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    A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine

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