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Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.

Primary Purpose

Migraine, Headache, Classic Migraine

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Topiramate
Sponsored by
Ortho-McNeil Neurologics, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Headache, Migraine Headache

Eligibility Criteria

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

Inclusion Criteria: To qualify for this study you must be 18-65 years old have a history of migraine headaches for at least 1 year experience at least 10 but less than 15 migraine headache days and less than 15 total headache days/month able to take oral medication able to understand and sign the informed consent and to complete headache diaries. Exclusion Criteria: You will not be able to participate in the study if you previously discontinued Topiramate because it did not make you feel better or it made you feel different have migraine aura without headache have a positive urine drug screen have a history of kidney stones have a history of suicide attempt pregnant females already on a migraine preventive medicine.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The primary efficacy parameter will be whether or not a patient experiences 15 or more headache days (migraine and non-migraine) during the last 28 days of the study.

    Secondary Outcome Measures

    Time to development of transformed migraine;occurrence of transformation as function of baseline headache days;change in the average rate of migraine days;percentage change in the average rate of migraine days;50%,75%, and 100% reduction in migraine days

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    May 17, 2011
    Sponsor
    Ortho-McNeil Neurologics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00212810
    Brief Title
    Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.
    Official Title
    TOPAMAX (Topiramate) Intervention to Prevent Transformation of Episodic Migraine: The Topiramate INTREPID Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Ortho-McNeil Neurologics, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether Topiramate is effective in preventing the development of chronic daily headache among patients with episodic migraine headaches.
    Detailed Description
    Chronic daily headache encompasses a frequent headache state in which the increased burden of pain further compromises quality of life and adversely impacts patients, their families, and health care providers. Approximately 5% of patients with migraine, or an estimated 1.4 million Americans, manifest a chronic daily headache form of disease. The consequences include resistance to treatment, worsening quality of life, increased use and over use of medication, and development of ischemic and other neuropathological brain lesions. This is a randomized, double-blind, placebo-controlled multicenter study that will enroll patients 18-65 years old with an established history of migraine headaches who, in the 28 days prior to the study should have a migraine frequency of at least 10 but less than 15 migraine headache days per month, and less than 15 total headache days (migraine plus non migraine headaches) per month. The study duration will be approximately 26 weeks. The study is divided into 4 phases as follows: A Screening/Washout Phase that may last between 2-6 weeks, depending on whether you need to stop taking a medication that is not allowed in the study; A Baseline Phase lasting 4 weeks, at which time information will be collected on the migraine and non-migraine headaches you experience during this period; A double-blind Titration Phase lasting 4-6 weeks where all patients will be randomized to treatment with either Topiramate or placebo. If you are randomized to Topiramate, your dose will be gradually increased up to a dose of either 75 or 100 mg a day; A Maintenance Period lasting 20 weeks at which time you will continue on the dose you were taking at the completion of the Titration period; and a Taper/Exit phase, lasting 2 weeks, where you will gradually reduce the dose of study medication you were taking during the study. The study hypothesis is that the study drug will be more effective than placebo in preventing patients from transforming from episodic migraines to chronic daily headaches. Each patient will be asked to record their headache pain information and medication use on paper headache diaries. Patients will receive either Topiramate or placebo. The number of tablets of topiramate or placebo, will be gradually increased to either a minimum of 3 tablets/day or a maximum of 4 tablets/day. For those on Topiramate, 3 tablets would represent 75 mg and 4 tablets would represent 100 mg/day.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    385 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Topiramate
    Primary Outcome Measure Information:
    Title
    The primary efficacy parameter will be whether or not a patient experiences 15 or more headache days (migraine and non-migraine) during the last 28 days of the study.
    Secondary Outcome Measure Information:
    Title
    Time to development of transformed migraine;occurrence of transformation as function of baseline headache days;change in the average rate of migraine days;percentage change in the average rate of migraine days;50%,75%, and 100% reduction in migraine days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To qualify for this study you must be 18-65 years old have a history of migraine headaches for at least 1 year experience at least 10 but less than 15 migraine headache days and less than 15 total headache days/month able to take oral medication able to understand and sign the informed consent and to complete headache diaries. Exclusion Criteria: You will not be able to participate in the study if you previously discontinued Topiramate because it did not make you feel better or it made you feel different have migraine aura without headache have a positive urine drug screen have a history of kidney stones have a history of suicide attempt pregnant females already on a migraine preventive medicine.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ortho McNeil Neurologics, Inc. Clinical Trial
    Organizational Affiliation
    Ortho-McNeil Neurologics, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20974598
    Citation
    Lipton RB, Silberstein S, Dodick D, Cady R, Freitag F, Mathew N, Biondi DM, Ascher S, Olson WH, Hulihan J. Topiramate intervention to prevent transformation of episodic migraine: the topiramate INTREPID study. Cephalalgia. 2011 Jan;31(1):18-30. doi: 10.1177/0333102410372427. Epub 2010 May 17.
    Results Reference
    derived
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=917&filename=CR002854_CSR.pdf
    Description
    The Topiramate INTREPID Study

    Learn more about this trial

    Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.

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