CHOCOlate MeLatonin for AdolescenT MigrainE



Status:Recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:3 - 17
Updated:7/26/2018
Start Date:September 25, 2017
End Date:September 1, 2022
Contact:Amy A Gelfand, MD
Email:amy.gelfand@ucsf.edu
Phone:415-885-7832

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CHOCOlate MeLatonin for AdolescenT MigrainE: The CHOCOLATE Study

Existing treatments for acute migraine are not effective for all children and adolescents,
and can cause side effects. We 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.

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. We will identify the most effective dose to pull forward into a future
fully-powered placebo-controlled efficacy study. If both doses are equally effective, we will
bring forward the best tolerated dose. If doses are equally well tolerated, we will bring
forward the lowest effective dose, as this will minimize cost to families should this
treatment become widely adopted.

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
We found this trial at
1
site
500 Parnassus Ave
San Francisco, California 94143
(415) 476-9000
Phone: 415-885-7832
University of California at San Francisco (UCSF) The leading university exclusively focused on health, UC...
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