CHOCOlate MeLatonin for AdolescenT MigrainE

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amy Gelfand; University of California, San Francisco
• Treatments: Melatonin

Criteria

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