NCT01581281

The Childhood and Adolescent Migraine Prevention Study

Amitriptyline and Topiramate in the Prevention of Childhood Migraine

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 488 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine
• Migraine Disorders
• Headache

Interventions

Type	Name	Description
DRUG	Amitriptyline	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.
DRUG	Topiramate	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.
DRUG	Placebo	Placebo will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance period.

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-04-01
• Completion: 2016-01-01
• First posted: 2012-04-20
• Last updated: 2017-08-10
• Results posted: 2017-08-10

Locations

35 sites across 1 country: United States