Migraine in adolescents is common and effective and safe preventive treatments are needed. This is a pilot randomized controlled trial of melatonin versus placebo for migraine prevention in adolescents 12-17 years old.
This is a pilot randomized controlled trial of melatonin vs. placebo for migraine prevention in adolescents 12-17 years old. The main goal of this pilot study is to estimate variance in the outcome measures to help with planning the future fully powered study. Participants will have an in person enrollment visit, followed by phone follow up visits and headache diary data collection via smart phone or internet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
UCLA Headache Research and Treatment Program
Los Angeles, California, United States
UCSF Pediatric Brain Center
San Francisco, California, United States
Number of Migraine/Migrainous Days Per 28 Day Period
Number of Migraine/Migrainous Days Per 28 Day Period in melatonin group and placebo group as measured using an online/mobile device headache diary.
Time frame: final 4 weeks of treatment
Number of Minutes to Sleep Onset
Number of minutes to sleep onset as measured by a FitBit.
Time frame: 16 weeks
Number of Participants Recruited From Each Recruitment Strategy
Each recruitment strategy will be analyzed for number of participants successfully enrolled.
Time frame: During the enrollment period, approximately 1 year
Medication Adherence as Measured by Number of Openings Per Participant
eCAP tack caps will be used to measure medication adherence and the number of openings will be recorded per participant.
Time frame: during the "At Home Active Study Period" or Weeks 5-16
Headache Diary Compliance Rate
Number of participants that had ≥85% headache diary compliance during weeks 12-16 of the study.
Time frame: Weeks 12-16 of the study
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