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Completed

NCT Number: NCT03597529

CHOCOlate MeLatonin for AdolescenT MigrainE

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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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, San Francisco, (UCSF)

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin

Drug

melatonin

Primary outcomes

  1. Change in Mean Visual Analog Scale (VAS) Score

    Time frame: Baseline (Time 0) and 2 hours

    Visual Analog Scale (VAS) score ranges from 0-10, measured in cm, 0 indicating no pain and 10 indicating the worst pain.

Sponsors and collaborators

Lead sponsor

Amy Gelfand

Other

Registry information

Official study title

CHOCOlate MeLatonin for AdolescenT MigrainE: The CHOCOLATE Study

Acronym: CHOCOLATE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2018
Registry last updated
Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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