Clinical trial NCT06808230: Cocoa Extract for Migraine Trial
Official title: Cocoa Flavanols for Migraine: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine
Keywords: migraine
cocoa extract
cocoa flavanol
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2025-02-05
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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

Primary outcomes:
measure: Recruitment
timeFrame: 15 months
measure: Retention
timeFrame: From run-in to end of treatment at 12 weeks
measure: Adherence
timeFrame: 12 week intervention period
Secondary outcomes:
measure: Migraine days
timeFrame: Four week run-in period and final four weeks of the 12 week intervention period
measure: Responder rate
timeFrame: Four week run-in period and final four weeks of the 12 week intervention period
measure: Migraine severity
timeFrame: Four week run-in period and final four weeks of the 12 week intervention period
measure: Adverse events
timeFrame: 12 week intervention period
measure: Reports of worsening of migraine symptoms
timeFrame: 12 week intervention period
measure: Allodynia Symptom Checklist
timeFrame: Baseline and end of the 12 week intervention period
measure: Headache Related Disability (HIT-6)
timeFrame: Baseline and end of the 12 week intervention period
measure: PROMIS-29
timeFrame: Baseline and end of the 12 week intervention period
measure: Urine levels of gamma-valerolactone metabolites (gVLM)
timeFrame: Four week run-in period and final four weeks of the 12 week intervention period
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Pamela M Rist, ScD
role: PRINCIPAL_INVESTIGATOR
References: