Conditions: Migraine in Adolescents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Group randomized to melatonin 3 mg orally nightly arm 2: Group randomized to placebo orally nightly

Interventions: intervention 1: Melatonin intervention 2: Placebo
Intervention descriptions: intervention 1: Taken at 9 PM or 1 hour before bedtime, whichever is earlier intervention 2: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier

Protocol document: