Conditions: Migraine Migraine Disorders Headache
Keywords: Pediatric Children Adolescent Headache Migraine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 488
Healthy volunteers: no

Brief summary:
The purpose of this research study is to test two medicines for migraine prevention in children and adolescents.

Detailed description:
The purpose of this research study is to test two medicines for migraine prevention in children and adolescents. The investigators want to see if amitriptyline and/or topiramate are better than placebo (sugar pill) in reducing headache frequency in children and adolescents ages 8 to 17 with migraines. At this time, there are no FDA approved medicines approved in the US for the prevention treatment of migraine headaches in children and adolescents.

Arms:
arm 1: Drug to be administered twice daily. arm 2: Drug to be administered twice daily. arm 3: To be administered twice daily.

Interventions: intervention 1: Amitriptyline intervention 2: Topiramate intervention 3: Placebo
Intervention descriptions: intervention 1: Amitriptyline will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. The morning dose is a placebo pill. Dosing of amitriptyline will be weight-based. intervention 2: Topiramate will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. Dosing of topiramate will be weight-based. intervention 3: Placebo will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance period.

Protocol document: