Back to resultsCHOCOlate MeLatonin for AdolescenT MigrainE (CHOCOLATE)
Primary Purpose
Migraine
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
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
Sites / Locations
- University of California, San Francisco, (UCSF)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low-Dose Melatonin (mg)
High-Dose Melatonin (mg)
Arm Description
melatonin 2mg (equal to or over 40kg) melatonin 1mg (under 40kg) Melatonin: melatonin
melatonin 8mg (equal to or over 40kg) melatonin 4mg (under 40kg) Melatonin: melatonin
Outcomes
Primary Outcome Measures
Change in Mean Visual Analog Scale (VAS) Score
Visual Analog Scale (VAS) score ranges from 0-10, measured in cm, 0 indicating no pain and 10 indicating the worst pain.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03597529
Brief Title
CHOCOlate MeLatonin for AdolescenT MigrainE
Acronym
CHOCOLATE
Official Title
CHOCOlate MeLatonin for AdolescenT MigrainE: The CHOCOLATE Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 25, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amy Gelfand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-Dose Melatonin (mg)
Arm Type
Experimental
Arm Description
melatonin 2mg (equal to or over 40kg) melatonin 1mg (under 40kg) Melatonin: melatonin
Arm Title
High-Dose Melatonin (mg)
Arm Type
Experimental
Arm Description
melatonin 8mg (equal to or over 40kg) melatonin 4mg (under 40kg) Melatonin: melatonin
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
melatonin
Primary Outcome Measure Information:
Title
Change in Mean Visual Analog Scale (VAS) Score
Description
Visual Analog Scale (VAS) score ranges from 0-10, measured in cm, 0 indicating no pain and 10 indicating the worst pain.
Time Frame
Baseline (Time 0) and 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy A Gelfand, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco, (UCSF)
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20713557
Citation
Victor TW, Hu X, Campbell JC, Buse DC, Lipton RB. Migraine prevalence by age and sex in the United States: a life-span study. Cephalalgia. 2010 Sep;30(9):1065-72. doi: 10.1177/0333102409355601. Epub 2010 Mar 12.
Results Reference
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PubMed Identifier
19223003
Citation
Ambriz-Tututi M, Rocha-Gonzalez HI, Cruz SL, Granados-Soto V. Melatonin: a hormone that modulates pain. Life Sci. 2009 Apr 10;84(15-16):489-98. doi: 10.1016/j.lfs.2009.01.024. Epub 2009 Feb 15.
Results Reference
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PubMed Identifier
22141591
Citation
Gitto E, Aversa S, Salpietro CD, Barberi I, Arrigo T, Trimarchi G, Reiter RJ, Pellegrino S. Pain in neonatal intensive care: role of melatonin as an analgesic antioxidant. J Pineal Res. 2012 Apr;52(3):291-5. doi: 10.1111/j.1600-079X.2011.00941.x. Epub 2011 Dec 5.
Results Reference
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CHOCOlate MeLatonin for AdolescenT MigrainE
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