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Amitriptyline and Topiramate in the Prevention of Childhood Migraine (The CHAMP Study)
Principal Investigator:  

Joshua M. Cohen, MD, MPH

Co-investigators:  

Adelene Jann, MD

Time frame of study:   Ongoing
Time frame of participation:   Approximately 10 months
Number of participants needed:   24
Location of Study:  

The Headache Institute
Mount Sinai St. Luke's Roosevelt
425 West 59th Street, Suite 4A
New York, NY 10019

Contact Name, Number & Email:  

Larissa Bonilla
lbonilla@chpnet.org
(212) 523-2381


Summary:
This is a multi-center, randomized, prospective clinical trial.  The purpose of this clinical trial is to test the effectiveness of two headache medications called amitriptyline and topiramate.  We want to see if amitriptyline and / or topiramate are better than placebo (sugar pill) in reducing headache frequency in children with migraines (ages 8 to 17).  Your child will be chosen to have one of these two medicines or the placebo by chance with a 1 in 5 chance that your child will be placed on the placebo. Neither your child nor your child’s study doctor will know which drug has been chosen by chance for you.

Criteria for Participation:
-Female or male of any racial/ethnic background
-Ages 8 to 17
-Migraine with/without aura confirmed diagnosis
-Migraine frequency based upon prospective headache diary of 28 days must be ≥ 4. Migraine frequency defined as any migraine during one day in the 28 day baseline period

Benefits/Compensation:
Evaluation and treatment by a board certified Migraine/Headache Neurologist. At each visit, your family will be reimbursed $80 for the costs/inconvenience/time (for example: travel, parking, and meals) associated with your participation in the research study. Your child will also receive gift cards for completing the headache diaries.  The total reimbursement for your family will be up to $810.