Status:
COMPLETED
A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Migraine
Common Migraine
Eligibility:
All Genders
12-65 years
Phase:
PHASE3
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 taken daily) compared with placebo in the prevention of migraine.
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the effectiveness and safety of three different doses of topiramate (50mg, 100mg, and 200mg daily...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2002
Estimated Enrollment :
763 Patients enrolled
Trial Details
Trial ID
NCT00236509
Start Date
February 1 2001
End Date
September 1 2002
Last Update
November 17 2010
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