At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 31 enrolled
Drug / intervention
Melatonin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Melatonin for Migraine Prevention in Adolescents: A Pilot Remote Trial: "The BRAiN-M Study"
In Brief
A Phase 2 clinical trial evaluating Melatonin and Placebo for Migraine in Adolescents. Completed, enrolled 31 participants across 2 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine in Adolescents
CountriesUnited States
CollaboratorsUniversity of California, Los Angeles
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartMay 2015
Primary CompletionApr 2016
TodayJul 2026
First PostedJan 22, 2015
Enrollment StartMay 1, 2015
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.4 years ago
Interventions
Melatonindrug
Taken at 9 PM or 1 hour before bedtime, whichever is earlier
Placeboother
Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier