A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate the Efficacy and Safety of Topiramate in the Prophylaxis of Migraine
1 other identifier
interventional
768
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2001
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedNovember 19, 2010
November 1, 2010
September 30, 2005
November 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in monthly (28 day) migraine period rate from the prospective baseline period to the double-blind phase.
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 14982912RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
March 1, 2001
Study Completion
November 1, 2002
Last Updated
November 19, 2010
Record last verified: 2010-11