Raising Money for
2014 MRF Research Grantee
FINAL REPORT: Examining whether melatonin, a safe and natural supplement, is effective for migraine prevention in 12-17 year-olds.
We enrolled 31 adolescents with migraine (ages 12-17 years) in a pilot randomized-placebo controlled trial to determine if melatonin was effective in reducing headache frequency in adolescents. We found that melatonin appears promising and safe for decreasing migraine frequency in adolescents, though larger studies are needed to determine this as this pilot study was designed to determine the feasibility of conducting a larger, fully-powered home-based trial. We successfully recruited participants into our predominantly home-based trial using innovative social media recruiting techniques. Adolescents were able to complete the majority of the trial from the comfort of their own homes, a convenience that was appreciated by many of the participants and parents.
Hypothesis vs Findings:
We hypothesized that conducting a predominantly home-based trial for adolescent migraine prevention would be feasible, and we indeed found this to be the case. Our pilot-study results support continuing to pursue melatonin as a migraine preventive in this age group. The average migraine days in the final 4 weeks of treatment was lower (though not statistically significantly so) in the melatonin treated group than in the placebo group: 3.6 vs. 4.9 (difference of -1.3 days per 4-weeks, 95% confidence interval for the difference -5.1 to 2.6). Sleep outcomes did not differ between groups, suggesting that melatonin’s benefit in migraine may be independent of effects on sleep. We have now cleared the way for conducting a larger trial that will definitively determine whether melatonin is effective for migraine prevention in this age group. Our hypothesis for the larger trial is that melatonin will decrease the number of migraine days that adolescents experience and that its safety and tolerability will be similar to that of placebo (i.e. sugar pill).
There is an urgent need in pediatric and adolescent migraine for preventive treatment strategies that are both effective and safe. The next step in our research will be to conduct a randomized double-blind placebo-controlled trial of melatonin that is large enough to determine whether melatonin is effective for migraine prevention in adolescents. We will also examine the tolerability of melatonin compared to placebo, by comparing adolescent sleepiness scores between those treated with melatonin and those treated with placebo.
What this Research Means to You:
Melatonin has been shown to be safe and effective for migraine prevention in adults. Our pilot study provides encouraging preliminary evidence that melatonin may be helpful for adolescents with migraine as well. If found to be effective, melatonin would be an inexpensive and accessible treatment to help adolescents with migraine.