Cocoa Extract for Migraine Trial

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Jan 29, 2025

Keywords

ClinConnect Summary

The Cocoa Extract for Migraine Trial is a study designed to explore whether high-dose cocoa extract can help people who suffer from episodic migraines. The researchers want to find out if they can recruit 114 participants and if those participants will consistently take the study pills throughout the trial. Participants will be divided into groups to receive either cocoa extract or a placebo (a pill with no active ingredients) and will need to take four pills a day for 12 weeks.

To be eligible for the study, individuals must be at least 18 years old and have a doctor-diagnosed history of migraines for at least a year, experiencing 4 to 14 migraine attacks in the month before joining. Participants will provide two urine samples, complete daily questionnaires about their headaches, and must be willing to use a smartphone app to track their progress. It's important to know that those with specific health issues, such as a history of stroke or certain neurological conditions, cannot participate. Overall, this trial aims to understand the potential benefits of cocoa extract for migraine relief while ensuring participants are supported throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Women and men aged ≥18 years
• • Self-reported clinician diagnosis of migraine with or without aura which does not meet criteria for chronic migraine (according to the International Classification of Headache Disorders 3rd edition)
• • Individuals with self-reported migraine will need to report a clinician diagnosis of migraine and be classified as having migraine or probable migraine by the American Migraine Study (AMS) migraine screener. The AMS migraine screener, which has a sensitivity of 100% and a specificity of 82% for the diagnosis of migraine will be used to confirm self-reported migraine status.
• • History of migraine dating for at least one year
• • Self-report of 4 to 14 migraine attacks during the 30 days prior to enrollment in the study
• • Completion of at least 22 headache diary days during the 28 day run-in period
• • o Report migraine frequency between 4 to 14 days during the 28 day run-in period
• • If currently using medications to prevent or treat migraine, no new medication use within the past 3 months
• • No new use of behavioral interventions within the past 3 months and/or agree to not begin new behavioral interventions during this trial
• • Be willing to complete all study procedures and be randomized to all interventional groups
• • Be fluent in English
• • Own an iPhone or Android device and be willing to download MyCap to the device
• Exclusion Criteria:
• • Self-reported history of stroke or transient ischemic attack; history of brain surgery or spine surgery; currently receiving treatment for a concussion; and self-reported diagnosis of cluster headache, brain tumor, brain aneurysm, traumatic brain injury, multiple sclerosis, epilepsy, schizophrenia, or bipolar disorder
• • Kidney failure or current dialysis treatment or any medical condition which the participant believes could lead to difficulty complying with the protocol
• • Current alcohol or substance abuse (self-reported)
• • Self-reported clinician diagnosis of medication overuse headache
• • Currently or recently (past 6 months) received Botox treatment for migraine
• • Failure to return the baseline urine sample
• • Currently pregnant, nursing, or intending to become pregnant during the study period.
• • Unwilling to forgo use of out-of-study supplements of cocoa extract during the trial
• • Extreme sensitivity to caffeine