Status:
COMPLETED
A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine Attacks in Children
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Migraine
Vascular Headaches
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with placebo in the prevention of migraine attacks in children (12 to 17 years of age).
Detailed Description
This is an outpatient, randomized, double-blind, placebo-controlled study to evaluate the effectiveness of 2 dosages of topiramate (50 and 100 milligrams/day) compared with placebo in the prevention o...
Eligibility Criteria
Inclusion
- History of migraine (with or without aura) conforming to International Headache Society (IHS) criteria for pediatric subjects for \>=6 months prior to screening
- Requires migraine prophylactic therapy, and if previously treated to prevent attacks, had unsatisfactory response to therapy
- Experienced an average of 3 to 12 migraine attacks and no more than 14 headache days per month during the 3 months prior to the study
- Females must be sexually abstinent, surgically sterile, or using adequate contraceptive measures, and have negative pregnancy tests before and during the study
Exclusion
- Currently taking or previously unable to tolerate topiramate, or previously failed therapy with topiramate for migraine prophylaxis
- Has mixed headaches and is unable to distinguish migraines from other headache types
- Overuses pain medications or specific agents for abortive treatment of migraine attacks
- Has a body mass index (BMI) greater than 40 or weighs more than 200 pounds, or is markedly underweight (below 5th percentile) for his or her age
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00210535
Start Date
June 1 2005
End Date
November 1 2006
Last Update
June 8 2011
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