The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.
The purpose of this study is to test two medicines— amitriptyline and topiramate—for migraine prevention in children and adolescents.
In the study, researchers will compare amitriptyline and topiramate to placebo (a sugar pill) and to one another to see if the study drugs are better than placebo in reducing headache frequency in children and adolescents ages 8 to 17 with migraines. At this time, there are no FDA (Food and Drug Administration)-approved medicines approved in the United States for the prevention of migraine headaches in children and adolescents.
The study will enroll 675 participants at up to 40 locations throughout the country, and will occur in three phases—screening, treatment, and weaning off medication.
During the 4-week screening phase, volunteers who consent and qualify will be asked to keep a headache diary, have a blood-draw and an electrocardiogram (ECG), and complete questionnaires. In phase two, the 24-week treatment phase, participants will be given either one of the two study drugs or placebo, and will be asked to daily track their headaches via a headache diary. Every four weeks participants will return to the study site for medical check-ins with the study staff. Questionnaires and blood will be taken at weeks 12 and 24. The last phase of the study, called the weaning off medication phase, will last 6 weeks. During this phase participants slowly will be weaned off of the study drugs, and will check in with the study staff via telephone two weeks and again 4 weeks after they have stopped the study medication.
For participants, this study includes at least 8 study site visits, and a total duration of about 34 weeks.
Please follow this link for trial eligibility information to share with your doctor.
Contact: Leigh Ann Chamberlin, RD, MEd; Tel: 513-636-9739; Email: firstname.lastname@example.org; or Leslie Korbee, BS, SI(ASCP); Tel: 513-803-1854; Email: email@example.com;
Last Reviewed February 6, 2014