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CHOCOlate MeLatonin for AdolescenT MigrainE (CHOCOLATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03597529
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Information provided by (Responsible Party):
Amy Gelfand, University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Melatonin Phase 2

Detailed 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. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CHOCOlate MeLatonin for AdolescenT MigrainE: The CHOCOLATE Study
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: melatonin 2mg (equal to or over 40kg)
melatonin 2mg (equal to or over 40kg)
Drug: Melatonin

Experimental: melatonin 8mg (equal to or over 40kg)
melatonin 8mg (equal to or over 40kg)
Drug: Melatonin

Experimental: melatonin 1mg (under 40kg)
melatonin 1mg (under 40kg)
Drug: Melatonin

Experimental: melatonin 4mg (under 40kg)
melatonin 4mg (under 40kg)
Drug: Melatonin

Primary Outcome Measures :
  1. change in VAS score [ Time Frame: 36 months ]
    change in VAS score

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03597529

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Contact: Amy A Gelfand, MD 415-885-7832

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United States, California
University of California, San Francisco, (UCSF) Recruiting
San Francisco, California, United States, 94158
Contact: Amy A. Gelfand, M.D.    415-885-7832   
Contact: Laura Dapkus, NCPT    415-860-2202   
Sponsors and Collaborators
University of California, San Francisco

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Responsible Party: Amy Gelfand, Assistant Professor of Neurology, University of California, San Francisco Identifier: NCT03597529     History of Changes
Other Study ID Numbers: 17-22645
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants