Status:
COMPLETED
A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho-McNeil Neurologics, Inc.
Conditions:
Vascular Headaches
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to evaluate the effectiveness and safety of topiramate (an epilepsy medication) compared with placebo in the prevention of migraine.
Detailed Description
Topiramate is a medication that is widely used for the treatment of adult and pediatric patients with seizures and has been shown in preliminary studies to be effective for migraine prevention in adul...
Eligibility Criteria
Inclusion
- Meet the criteria of the International Headache Society for the classification of migraine with or without aura (migraine symptoms)
- Diagnosis of migraine for at least 12 months prior to start of the study
- Have had an average of 3 to 8 migraine attacks per month for the 3 months prior to the start of the study
- Ability to recognize migraine headaches and to distinguish them from tension-type headaches or other types of head pain
- General good health
Exclusion
- Patients who previously failed to respond to topiramate therapy for migraine prevention or who discontinued topiramate due to adverse events
- Patients who had onset of migraine after age 50
- Patients having more than 15 headache-days per month during the 3 months prior to start of the study, or during the baseline (pretreatment) period
- Patients who have cluster headaches or who have exclusively aura (migraine symptoms) without headache
- Female patients who are pregnant, nursing, or those not using adequate birth control, if capable of bearing children
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2001
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT00253175
Start Date
October 1 2000
End Date
December 1 2001
Last Update
April 28 2010
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