CHOCOlate MeLatonin for AdolescenT MigrainE

Phase 2

Completed

• Conditions: Migraine
• Interventions: Drug: Melatonin

• Registration Number: NCT03597529
• Lead Sponsor: Amy Gelfand

Brief Summary

Existing treatments for acute migraine are not effective for all children and adolescents, and can cause side effects. Investigator propose a dose-finding study of melatonin for acute migraine treatment in children and adolescents to determine the best dose to bring forward in a future fully-powered efficacy trial.

Detailed Description

This pilot randomized trial is a dose-finding study to determine which dose of melatonin is most effective for treating acute migraine in children and adolescents who have episodic migraine. Investigator will identify the most effective dose to pull forward into a future fully-powered placebo-controlled efficacy study. If both doses are equally effective, Investigator will bring forward the best tolerated dose. If doses are equally well tolerated, Investigator will bring forward the lowest effective dose, as this will minimize cost to families should this treatment become widely adopted.

Study Timeline

• Study First Submitted: 2017-06-26
• Study Start: 2017-09-25
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-24
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Disposition First Submitted: 2021-01-27
• Results First Submitted: 2021-04-20
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-19
• Disposition First Submitted QC: 2021-05-19
• Last Update Submitted: 2021-05-19
• Results First Posted: 2021-06-15
• Disposition First Posted: 2021-06-15
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Meet ICHD criteria for episodic migraine in children and adolescents, with at least 1 migraine attack per month on average.
2. Age 3-17 years
3. Dissatisfaction with previous acute treatments, for one or more of the following reasons: a) One or more previously tried acute medications have not been effective, or adequately effective, b) previously tried acute treatments have caused side effects, or C) patient/family would prefer a natural supplement for acute treatment over medication treatment
4. If of driving age, teen participant agrees not to drive for at least 8 hours after treating with melatonin.

Exclusion Criteria

1. Allergy or intolerance to melatonin, or to chocolate.
2. Opioid or barbiturate overuse as defined in ICHD
3. Pregnant/lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-Dose Melatonin (mg)	Melatonin	melatonin 2mg (equal to or over 40kg) melatonin 1mg (under 40kg) Melatonin: melatonin
High-Dose Melatonin (mg)	Melatonin	melatonin 8mg (equal to or over 40kg) melatonin 4mg (under 40kg) Melatonin: melatonin

Primary Outcome Measures

Name	Time	Method
Change in Mean Visual Analog Scale (VAS) Score	Baseline (Time 0) and 2 hours	Visual Analog Scale (VAS) score ranges from 0-10, measured in cm, 0 indicating no pain and 10 indicating the worst pain.

Trial Locations

Locations (1)

University of California, San Francisco, (UCSF); 🇺🇸 San Francisco, California, United States