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


Study is Available At:


Original ID:

17-22645


NCT ID:

NCT03597529


Secondary ID:


Study Acronym:

CHOCOLATE


Brief Title:

CHOCOlate MeLatonin for AdolescenT MigrainE


Official Title:

CHOCOlate MeLatonin for AdolescenT MigrainE: The CHOCOLATE Study


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

3 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Francisco


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

83


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:September 25, 2017
Completion Date:December 1, 2019
Completion Type:Actual
Primary Completion Date:December 1, 2019
Primary Completion Type:Actual
Verification Date:January 2021
Last Changed Date:January 27, 2021
First Received Date:June 26, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:change in VAS score
Time Frame:36 months
Safety Issues:False
Description:change in VAS score

Study Interventions

Intervention Type:Drug
Name:Melatonin
Description:melatonin
Arm Name:melatonin 1mg (under 40kg)

Study Arms

Study Arm Type:Experimental
Arm Name:melatonin 4mg (under 40kg)
Description:melatonin 4mg (under 40kg)
Study Arm Type:Experimental
Arm Name:melatonin 1mg (under 40kg)
Description:melatonin 1mg (under 40kg)
Study Arm Type:Experimental
Arm Name:melatonin 8mg (equal to or over 40kg)
Description:melatonin 8mg (equal to or over 40kg)
Study Arm Type:Experimental
Arm Name:melatonin 2mg (equal to or over 40kg)
Description:melatonin 2mg (equal to or over 40kg)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Francisco

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.
PMID:22141591
Reference Type:Reference
Citation:Ambriz-Tututi M, Rocha-González 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. Review.
PMID:19223003
Reference Type:Reference
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.
PMID:20713557

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.