High-dose cocoa extract for adults with episodic migraine
Cocoa Flavanols for Migraine: A Pilot Study
This will see if adults with episodic migraine can enroll and stick to taking high-dose cocoa extract pills daily for 12 weeks, compared with lower-dose and placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06808230 on ClinicalTrials.gov |
What this trial studies
This single-center randomized trial at Brigham and Women's Hospital compares two doses of oral cocoa extract to placebo to test feasibility of recruitment and daily pill adherence in adults with episodic migraine. Participants complete a 28-day run-in with headache diaries, provide two urine samples, complete daily questionnaires, and take four study pills per day for 12 weeks. The main goals are to determine whether 114 participants can be enrolled during the recruitment period and the proportion who adhere to daily pill taking. Results will guide whether higher-dose cocoa extract is acceptable and whether a larger efficacy trial is feasible.
Who should consider this trial
Good fit: Adults aged 18 or older with a clinician diagnosis of episodic migraine (4–14 migraine days per 28–30 days), migraine history of at least one year, and willingness to complete daily diaries, provide urine samples, and take four pills daily are ideal candidates.
Not a fit: People with chronic migraine (more than 14 migraine days per month), fewer than 4 migraine days monthly, those unable to take pills daily or complete diaries, or those seeking immediate symptom relief are unlikely to benefit from this feasibility trial.
Why it matters
Potential benefit: If feasible, the trial could enable larger studies to test whether cocoa extract helps reduce migraine frequency or severity.
How similar studies have performed: This approach is relatively novel for migraine—cocoa flavanols have been studied for vascular and cognitive effects but there are few large trials testing high-dose cocoa extract specifically for migraine.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Pamela M Rist, ScD — Brigham and Women's Hospital
- Study coordinator: Pamela M Rist, ScD
- Email: bwhcoral@mgb.org
- Phone: 877-517-2555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.