Clinical Studies
Breast Care
Cardiology
Colon Cancer
Dermatology
Diabetes
Gastrointestinal
HIV/AIDS
Mental Health
Neurology
NeuroOphthalmology
Obesity/Weight Management
Women's Health
Other
Special Features
Advances/Research
| Principal Investigator: |
|
||
| 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 |
||
| Contact Name, Number & Email: | Larissa Bonilla |
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.