Status:
COMPLETED
A Study of the Efficacy and Safety of Two Doses of Topiramate Compared to Placebo and Propranolol 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 two doses of topiramate (100 and 200 mg daily) versus placebo and propranolol in the prevention of migraine. The study will also ass...
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of two doses of topiramate versus placebo and propranolol in the preventio...
Eligibility Criteria
Inclusion
- Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 1 year 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 :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
786 Patients enrolled
Trial Details
Trial ID
NCT00236561
Start Date
April 1 2001
End Date
December 1 2002
Last Update
November 19 2010
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