CHOCOlate MeLatonin for AdolescenT MigrainE

Migraine Clinical Trial

— CHOCOLATE  

Official title:

CHOCOlate MeLatonin for AdolescenT MigrainE: The CHOCOLATE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597529
• Other study ID #: 17-22645
• Status: Completed
• Phase: Phase 2
• Start date: September 25, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: May 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Melatonin
melatonin

Locations

Country	Name	City	State
United States	University of California, San Francisco, (UCSF)	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Amy Gelfand

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Time 0) and 2 hours