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

May 17, 2011 updated by: Ortho-McNeil Neurologics, Inc.

TOPAMAX (Topiramate) Intervention to Prevent Transformation of Episodic Migraine: The Topiramate INTREPID Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

385

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ortho-McNeil Neurologics, Inc.

Investigators

  • Study Director: Ortho McNeil Neurologics, Inc. Clinical Trial, Ortho-McNeil Neurologics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 17, 2011

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002854

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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