CHOCOlate MeLatonin for AdolescenT MigrainE (CHOCOLATE)

Amy Gelfand

Status and phase: Completed; Phase 2

Conditions: Migraine

Treatments: Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT03597529

17-22645

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 84 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Low-Dose Melatonin (mg)

Experimental group

Description:

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

Treatment:

Drug: Melatonin

High-Dose Melatonin (mg)

Experimental group

Description:

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

Treatment:

Drug: Melatonin