Summary

for people ages 3-17 (full criteria)
at San Francisco, California
study started
estimated completion:
Amy Gelfand

Description

Summary

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.

Official Title

CHOCOlate MeLatonin for AdolescenT MigrainE: The CHOCOLATE Study

Details

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.

Keywords

Migraine Migraine Disorders Melatonin melatonin 1mg (under 40kg) melatonin 4mg (under 40kg)

Eligibility

You can join if…

Open to people ages 3-17

  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.

You CAN'T join if...

  1. Allergy or intolerance to melatonin, or to chocolate.
  2. Opioid or barbiturate overuse as defined in ICHD
  3. Pregnant/lactating

Location

  • University of California, San Francisco, (UCSF) accepting new patients
    San Francisco California 94158 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03597529
Phase
Phase 2
Lead Scientist
Amy Gelfand
Study Type
Interventional
Last Updated
July 13, 2018