UCSF BRAiN-M Study

THE FUTURE: We hope this study leads to the discovery of a safe and effective treatment of migraine in adolescents. We also hope this study leads to great improvements in the speed, cost, and availability of clinical trials for families of children with migraine. For more information: Please contact a member of the BRAiN-M study team at [email protected] or 415-885-7832.

How does the study work? The study involves 4 basic steps, which are described below: STEP 1: OFFICE VISIT: The only office visit required is a 2 hour visit with you and your adolescent to discuss their migraine and medical history. We will discuss all of the important details of the study and ask you and your adolescent to sign a document that describes the study and what to expect. This document is called the Informed Consent.... STEP 2: AT HOME SCREENING PERIOD (4 WEEKS): Once you have signed the informed consent document and your adolescent is considered to be eligible to participate, we will send you home with instructions on how to complete the headache diary from a smart phone or online. We will have your adolescent record his or her headache pattern each night before bed. For a week they will also wear the Fitbit at night to record sleep data. STEP 3: AT HOME ACTIVE STUDY PERIOD (12 WEEKS): If your adolescent is considered to be eligible to continue into the active study period, four things will happen: Your adolescent will be randomly assigned to take either melatonin or a placebo (sugar pill), which will be sent by FedEx using overnight mail. A parent must sign to indicate receipt of this package. Your adolescent will take the study medication at 9:00 pm each evening or one hour before bedtime, whichever is earlier. Each night of the 12-week active study period, your adolescent will complete the headache diary either online or on the smart phone. They will answer questions about whether they had a headache that day. Then they should take their study medication. (It is a good idea to set up a bedtime routine where they complete their diary for the day and then take their study medication). If you are concerned about a side effect, you can report it by calling us. During week nine your adolescent will wear the Fitbit again at night to help us record their sleep patterns. On the last day of Week 12, a text message will be sent to remind you and your adolescent to mail back the medication bottle in a provided FedEx envelop. You will be provided with a link to click on and let us know what day the envelope was mailed. STEP 4: ONCE STUDY IS COMPLETED FOR ALL PARTICIPANTS: Once the entire study is completed and the results have been analyzed and presented at a scientific meeting, we will e-mail you to give you the study results and tell you whether your adolescent was taking melatonin or placebo. (This may take 6-12 months after you complete the study).

Will I receive compensation for my time? If your adolescent completes the entire study, you and your adolescent will receive up to $95 as follows: we will give you one $25 gift card after completing visit one. Up to $20 in gift cards can be received for completing 80% of the headache diaries, and two $25 gift cards upon study completion, (one for the adolescent, one for the parent(s)) to help compensate for your time and effort. The Fitbit device is also a gift for your adolescent to keep.

Where do I fill out all of the questionnaires? You will complete all of the study questionnaires online or on a smart phone wherever you have internet access. We recommend your adolescent complete the headache diary each night as part of a routine.

How long does the study take? The study is 16 weeks long. If your adolescent is eligible, your time commitment will be approximately: One 2-hour office visit to fill out initial paperwork and have a neurologic examination and headache history (Girls who have had their first period will also have a urine pregnancy test).... 5 minutes per day (via internet or smart phone) for sixteen weeks to record headache diary data Total time commitment: approximately 10-12 hours over 16 weeks