Cocoa Extract for Migraine Trial

Last updated: July 9, 2025
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Headaches

Chronic Pain

Treatment

Cocoa extract

Cocoa extract placebo

Clinical Study ID

NCT06808230
2024P003655
U01AT012611
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to assess the feasibility of recruitment and adherence to a high-dose cocoa extract supplement in individuals diagnosed with episodic migraine. The main questions it aims to answer are:

  • Will we be able to enroll 114 participants during the recruitment period?

  • Will participants take study pills daily during the pill-taking period?

Researchers will compare two doses of cocoa extract to placebo to determine the acceptability of higher doses of cocoa extract supplementation in this patient population.

Participants will be asked to:

  • Provide two urine samples

  • Complete daily questionnaires

  • Take four study pills a day for 12 weeks

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women and men aged ≥18 years

  • Self-reported clinician diagnosis of migraine with or without aura which does notmeet criteria for chronic migraine (according to the International Classification ofHeadache Disorders 3rd edition)

  • Individuals with self-reported migraine will need to report a cliniciandiagnosis of migraine and be classified as having migraine or probable migraineby the American Migraine Study (AMS) migraine screener. The AMS migrainescreener, which has a sensitivity of 100% and a specificity of 82% for thediagnosis 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 inthe 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 usewithin the past 3 months

  • No new use of behavioral interventions within the past 3 months and/or agree to notbegin new behavioral interventions during this trial

  • Be willing to complete all study procedures and be randomized to all interventionalgroups

  • Be fluent in English

  • Own an iPhone or Android device and be willing to download MyCap to the device

Exclusion

Exclusion Criteria:

  • Self-reported history of stroke or transient ischemic attack; history of brainsurgery or spine surgery; currently receiving treatment for a concussion; andself-reported diagnosis of cluster headache, brain tumor, brain aneurysm, traumaticbrain injury, multiple sclerosis, epilepsy, schizophrenia, or bipolar disorder

  • Kidney failure or current dialysis treatment or any medical condition which theparticipant 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 studyperiod.

  • Unwilling to forgo use of out-of-study supplements of cocoa extract during the trial

  • Extreme sensitivity to caffeine

Study Design

Total Participants: 114
Treatment Group(s): 2
Primary Treatment: Cocoa extract
Phase:
Study Start date:
June 23, 2025
Estimated Completion Date:
December 01, 2026

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.