Cocoa Extract for Migraine Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cocoa extract, Cocoa extract placebo.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cocoa Flavanols for Migraine: A Pilot Study
Overview
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
Interventions
- Dietary supplement Cocoa extract
Cocoa extract manufactured as 250 mg capsules - Dietary supplement Cocoa extract placebo
Cocoa extract placebo
Primary outcome measures
- Recruitment [Time frame: 15 months]
- Retention [Time frame: From run-in to end of treatment at 12 weeks]
- Adherence [Time frame: 12 week intervention period]
Secondary outcome measures (9)
- Migraine days [Time frame: Four week run-in period and final four weeks of the 12 week intervention period]
- Responder rate [Time frame: Four week run-in period and final four weeks of the 12 week intervention period]
- Migraine severity [Time frame: Four week run-in period and final four weeks of the 12 week intervention period]
- Adverse events [Time frame: 12 week intervention period]
- Reports of worsening of migraine symptoms [Time frame: 12 week intervention period]
- Allodynia Symptom Checklist [Time frame: Baseline and end of the 12 week intervention period]
- Headache Related Disability (HIT-6) [Time frame: Baseline and end of the 12 week intervention period]
- PROMIS-29 [Time frame: Baseline and end of the 12 week intervention period]
- Urine levels of gamma-valerolactone metabolites (gVLM) [Time frame: Four week run-in period and final four weeks of the 12 week intervention period]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Brigham and Women's Hospital — Boston
Identifiers
NCT: NCT06808230 · 2024P003655 · U01AT012611