CHOCOlate MeLatonin for AdolescenT MigrainE

Completed · Phase 2

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT03597529

Run by

Amy Gelfand

People needed

84

Starts

2017-09-25

Expected to finish

2019-12-01

Last updated by the study team

2021-06-15

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet ICHD criteria for episodic migraine in children and adolescents, with at least 1 migraine attack per month on average.
• Age 3-17 years
• 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
• If of driving age, teen participant agrees not to drive for at least 8 hours after treating with melatonin.

You may not qualify if…

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

Where it is running

• University of California, San Francisco, (UCSF) — San Francisco, California, United States

Full record on ClinicalTrials.gov

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