Cocoa Extract for Migraine Trial
ConditionMigraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cocoa extract
Dietary supplementCocoa extract manufactured as 250 mg capsules
Cocoa extract placebo
Dietary supplementCocoa extract placebo
Treatment groups
114 Participants
are divided into 3 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: 500 mg cocoa extractExperimental treatment 1 intervention
Group C: 1000 mg cocoa extractExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment
We will be able to recruit and randomize 114 eligible individuals
Time frame
15 months2
Retention
Retention will be quantified by the proportion of subjects who record their migraines for at least 22 out of 28 days during run-in and the last four weeks of the intervention and complete all questionnaires at baseline and follow-up
Time frame
From run-in to end of treatment at 12 weeks3
Adherence
Adherence will be calculated as the proportion of participants who miss no more than 12 days of study pills (i.e. participants will consume study pills on 85% of the intervention days)
Time frame
12 week intervention periodSecondary outcomes
1
Migraine days
Number of migraine attacks as recorded in migraine diaries
Time frame
Four week run-in period and final four weeks of the 12 week intervention period2
Responder rate
Proportion of individuals who experience a ≥50% reduction in migraine days
Time frame
Four week run-in period and final four weeks of the 12 week intervention period3
Migraine severity
Four-point scale with categories of "absent, mild, moderate, or severe".
Time frame
Four week run-in period and final four weeks of the 12 week intervention period4
Adverse events
Potential side effects and adverse events
Time frame
12 week intervention periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov