CHOCOlate MeLatonin for AdolescenT MigrainE

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-25

Study Completion Date

2019-12-01

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.

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low-Dose Melatonin (mg)

melatonin 2mg (equal to or over 40kg) melatonin 1mg (under 40kg) Melatonin: melatonin

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

melatonin

High-Dose Melatonin (mg)

melatonin 8mg (equal to or over 40kg) melatonin 4mg (under 40kg) Melatonin: melatonin

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

melatonin

Interventions

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Melatonin

melatonin

Intervention Type DRUG

Eligibility Criteria

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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.