Melatonin for Adolescent Migraine Prevention: A Pilot Internet-based Randomized Controlled Trial (P2.163)

Objective: To assess the feasibility of conducting an adolescent migraine prevention trial of melatonin predominantly via the internet. Background: Adolescent migraine is common, yet few migraine preventive therapies have been studied in this age group. Melatonin is safe and effective for migraine prevention in adults. We conducted a randomized trial in which most of the procedures were performed from the convenience of the participants’ homes. Design/Methods: Adolescents (12–17 y.o.) with 2–24 migraine days/month were recruited and screened using online advertising and targeted invitations. Following a one-time in-person enrollment visit, participants completed a 28-day baseline headache diary on their smartphones. Subjects who met randomization criteria were randomized 1:1 to melatonin 3 mg or placebo for 12-weeks. The enrollment goal was 30 participants. Results: Thirty-one participants were enrolled at a single site, and 26 met randomization criteria (n=13 per group). Baseline characteristics were comparable except for a higher mean PedMIDAS score in the melatonin group: 51±29 vs. 31±28, p=0.04. Baseline mean migraine days/month were similar: 6.4±4.6 (placebo) vs. 5.6±3.2 (melatonin). Outcome data were available for 23/26 (89%). In the third month of treatment, mean migraine days/month was: 4.9±5.5 (placebo) vs. 3.6±3.0 in the melatonin group (p=0.83, delta −1.3 days). In a secondary analysis adjusted for baseline PedMIDAS score, mean migraine days/month in the melatonin group was −2.3 days lower than in the placebo group (95% CI −6.3 to 1.8, p=0.25). There were no serious adverse events. One participant in the melatonin group stopped study drug due to daytime tiredness. Estimates of efficacy and variance in our main endpoint measurements indicate that an efficacy trial would require outcome data on 42 participants/arm. Conclusions: It is feasible to conduct a migraine preventive trial in adolescents via the internet. These preliminary data suggest that melatonin may reduce the frequency of adolescent migraine and inform design of a fully-powered internet-based trial. Study Supported by: UCSF CTSI, NIH/NCATS TR001870-01, the Migraine Research Foundation, the Irene Perstein Award and an anonymous family philanthropic donation. Disclosure: Dr. Gelfand has received personal compensation for activities with for Eli Lilly, Zosano, and Teva as a consultant and for travel expenses. Dr. Gelfand has received research suppor from eNeura, EMKinetics, and Allergan. Dr. Qubty has nothing to disclose. Dr. Patniyot has nothing to disclose. Dr. Pletcher has received research support from ZOLL. Dr. Goadsby has received personal compensation for activities with Allergan, eNeura, Autonomic Technologies Inc, Amgen, AlderBio, Pfizer, DrReddy, Zosano, Colucid, Eli Lilly, Avanir, Gore,Heptares, Nupathe, Teva, Cipla, Ajinomoto, Akita,Wells Fargo, Ethicon,Promius. Dr. Goadsby has received personal compensation in an editorial capacity for JournalWatch Neurology and UptoDate. Dr. Goadsby has received research supporting from Amgen, eNeura, Allergan. Dr. Cummings has received personal compensation for activities with Lilly, Merck, Radius, Amgen, Inc., Sermonix, Regeneron, Calico, Grail, and Google Research.