Clinical trial NCT03597529: CHOCOlate MeLatonin for AdolescenT MigrainE
Official title: CHOCOlate MeLatonin for AdolescenT MigrainE: The CHOCOLATE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 84
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Mean Visual Analog Scale (VAS) Score
timeFrame: Baseline (Time 0) and 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco, (UCSF)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Amy A Gelfand, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.