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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03597529
Recruitment Status : Completed
First Posted : July 24, 2018
Results First Posted : June 15, 2021
Last Update Posted : June 15, 2021
Sponsor:
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. 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.

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. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 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
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine
Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Low-Dose Melatonin (mg)
melatonin 2mg (equal to or over 40kg) melatonin 1mg (under 40kg) Melatonin: melatonin
Drug: Melatonin
melatonin

Experimental: High-Dose Melatonin (mg)
melatonin 8mg (equal to or over 40kg) melatonin 4mg (under 40kg) Melatonin: melatonin
Drug: Melatonin
melatonin




Primary Outcome Measures :
  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.



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
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

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 ClinicalTrials.gov identifier (NCT number): NCT03597529


Locations
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United States, California
University of California, San Francisco, (UCSF)
San Francisco, California, United States, 94158
Sponsors and Collaborators
Amy Gelfand
Investigators
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Principal Investigator: Amy A Gelfand, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by Amy Gelfand, University of California, San Francisco:
Publications:
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Responsible Party: Amy Gelfand, Assistant Professor of Neurology, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03597529    
Other Study ID Numbers: 17-22645
First Posted: July 24, 2018    Key Record Dates
Results First Posted: June 15, 2021
Last Update Posted: June 15, 2021
Last Verified: May 2021
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
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants