CHOCOlate MeLatonin for AdolescenT MigrainE

Study Overview
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Brief Summary
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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
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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.

Official Title
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CHOCOlate MeLatonin for AdolescenT MigrainE: The CHOCOLATE Study

Conditions
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Migraine

Intervention / Treatment
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* Drug: Melatonin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Allergy or intolerance to melatonin, or to chocolate. Opioid or barbiturate overuse as defined in ICHD Pregnant/lactating

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-Dose Melatonin (mg)<br>melatonin 2mg (equal to or over 40kg) melatonin 1mg (under 40kg) Melatonin: melatonin | Drug: Melatonin<br>* melatonin<br>|
| Experimental: High-Dose Melatonin (mg)<br>melatonin 8mg (equal to or over 40kg) melatonin 4mg (under 40kg) Melatonin: melatonin | Drug: Melatonin<br>* melatonin<br>|

What is the study measuring?
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Primary Outcome Measures

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