Clinical Trial: Melatonin for Adolescent Migraine Prevention Study
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Melatonin for Adolescent Migraine Prevention Study (The MAP Study).
Brief Summary: This will be a randomized, multi-site double-blind placebo-controlled trial of melatonin (2 different dosing arms) vs. placebo for migraine prevention in adolescents. We intend to enroll approximately 210 participants over 15 months at two sites: UCLA and UCSF. The duration of participation for each participant will be 4 months.
Detailed Summary:
Participation includes 16 weeks of daily headache diary recording and taking the study pill every night, 1-2 hours before bed. Aside from the initial 1 hour enrollment visit, all remaining study procedures will be completed from home.
During the enrollment visit, history of migraine, questionnaires, a neurologic and physical exam (including weight, blood pressure, pulse, and respiratory rate) will be performed. Girls who have had their first period will undergo a urine pregnancy test and will be instructed to use birth control if they are sexually active.
For the first 8 week phase, participants will be instructed to take one study pill every night, 1-2 hours before bedtime and complete a daily headache diary from a smartphone. Phone call check-ins will occur at week 4 and week 8.
After the first 8 weeks of the study, participants who are eligible for the second phase of the study will be notified by study staff and will be sent the next set of study pills. Again, participants will be instructed to take the study pill every night, 1-2 hours before bedtime and complete a diary entry every evening.
Phone call check-ins will occur at week 12 and week 16. At the final 16 week phone call, additional questionnaires and study completion feedback will be collected.
Sponsor: Amy Gelfand
Current Primary Outcome: Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin treated participants vs. placebo. [ Time Frame: weeks 5-8 of randomized treatment phase ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin 6 mg vs. placebo. [ Time Frame: Weeks 5-8 of randomized treatment phase. ]
- Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin 3 mg vs. placebo. [ Time Frame: Weeks 5-8 of randomized treatment phase. ]
- Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin 6 mg vs. melatonin 3 mg. [ Time Frame: Weeks 5-8 of randomized treatment phase. ]
- Change in mean migraine/migrainous days from weeks 5-8 of single-blind treatment phase to weeks 5-8 of randomized treatment phase for each group. [ Time Frame: Weeks 5-8 of single-blind treatment phase to weeks 5-8 of randomized treatment phase. ]
- Mean PedMIDAS (headache related disability score) in weeks 5-8 of randomized treatment phase in each melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons. [ Time Frame: Weeks 5-8 of randomized treatment phase. ]
- Mean CASQ score in weeks 5-8 of randomized treatment phase in melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons. [ Time Frame: Weeks 5-8 of randomized treatment phase. ]
- Number of days acute medication is used in weeks 5-8 of randomized treatment phase in melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons. [ Time Frame: Weeks 5-8 of randomized treatment phase. ]
- Number of headache days in weeks 5-8 of randomized treatment phase in melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons. [ Time Frame: Weeks 5-8 of randomized treatment phase. ]
Original Secondary Outcome: Same as current
Information By: University of California, San Francisco
Dates:
Date Received: May 10, 2017
Date Started: June 15, 2017
Date Completion: June 2020
Last Updated: May 10, 2017
Last Verified: May 2017
