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A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine
This study has been completed.
First Received: September 30, 2005   Last Updated: May 11, 2007   History of Changes
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00231595
  Purpose

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.


Condition Intervention Phase
Classic Migraine
Migraine
Headache
Common Migraine
Drug: topiramate
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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.

Estimated Enrollment: 480
Study Start Date: December 2000
Estimated Study Completion Date: November 2002
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.

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231595

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Publications:
Study ID Numbers: CR003208
Study First Received: September 30, 2005
Last Updated: May 11, 2007
ClinicalTrials.gov Identifier: NCT00231595     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Migraine
Prophylaxis
Classic Migraine
Topiramate
Prevention
Headache
Common Migraine

Additional relevant MeSH terms:
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Pain
Headache Disorders, Primary
Brain Diseases
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Headache Disorders
Anti-Obesity Agents
Signs and Symptoms
Migraine Disorders
Therapeutic Uses
Headache
Neurologic Manifestations
Topiramate
Migraine with Aura
Central Nervous System Agents
Anticonvulsants
Migraine without Aura

ClinicalTrials.gov processed this record on November 27, 2009