A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Preventing Migraine Headaches in Children

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and efficacy of topiramate as compared to placebo in preventing migraines in children.

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

Details

• Lead Sponsor: Ortho-McNeil Neurologics, Inc.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Children who have had several attacks of headaches that meet the International Headache Society Classification of pediatric migraine with or without aura (for example, headache lasts up to 48 hours, has a throbbing quality, is accompanied by nausea or sensitivity to light, is made worse by physical activity)

• Average of 3 to 10 migraine days per month for previous 3 months

• Weighs more than 20 kilograms (44 pounds)

• Able to swallow a tablet whole (without crushing it)

Exclusion Criteria:

• Took topiramate previously to prevent migraines but it was not effective

• Had to stop taking topiramate because of side effects

• Presence of cluster headaches, migraine aura without headache

• Had taken any medications for migraine prevention within 2 weeks before study start

• Presence of active liver disease or abnormal kidney function