Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 3

Conditions

Migraine

Headache

Treatments

Drug: topiramate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00210821

CR004666

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness and safety of two treatment regimens in preventing migraines. The antidepressant amitriptyline has been used successfully to prevent migraine headaches.

Full description

People who suffer from migraines have many prescription medications to choose from, both to treat the migraine and to prevent it from starting. However, many patients have not had success in finding the drug that helps them best. Amitriptyline, an antidepressant, has been used successfully for many years to prevent migraine headaches. This study will compare the effectiveness of amitriptyline with the effectiveness of topiramate, an anti-seizure drug, in preventing migraines. The safety of both drugs will also be assessed. The objective of the study is to demonstrate that topiramate will be at least as effective as amitriptyline in preventing migraines. During the first 4 weeks of the study, topiramate or amitriptyline will be increased by 25 mg per week up to a total dose of 100 mg per day or up to the maximum tolerated dose, whichever is less. Treatment will continue at 100 mg per day for 22 weeks.

Enrollment

347 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Migraine headache for at least 6 months, with 3 to 12 headaches a month for the previous 3 months
no more than 15 headache days in the previous month before study start
no heart rhythm problems or neurologic problems
women must not be pregnant and must use birth control

Exclusion criteria