San Francisco, California 94158

  • Migraine

Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT03597529


Primary Contact:

Principal Investigator
Amy A Gelfand, MD
University of California, San Francisco


Backup Contact:

N/A


Location Contact:

San Francisco, California 94158
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 16, 2021

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