NCT06808230Active, not recruiting
Cocoa Extract for Migraine Trial
Cocoa Flavanols for Migraine: A Pilot Study
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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 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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 29 Jan 2025
- Start date
- 23 Jun 2025
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Migraine
- NCT number
- NCT06808230
What you commit to
- Study type: Interventional
- Planned participants: 114
- From 23 Jun 2025 to the primary completion date, 1 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Self-reported clinician diagnosis of medication overuse headache
- Currently or recently (past 6 months) received Botox treatment for migraine
Other illness
- Kidney failure or current dialysis treatment or any medical condition which the participant believes could lead to difficulty complying with the protocol
- Failure to return the baseline urine sample
Other
- Current alcohol or substance abuse (self-reported)
- 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
Who the study is looking for
- 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 20 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.