A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine Attacks in Children

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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