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Cocoa Flavanols for Migraine: A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Pamela M Rist, ScD
bwhcoral@mgb.org
877-517-2555
Time Frame
Start Date: 2025-06-23
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 114
Treatments
Placebo_comparator: Placebo
Participants assigned to this arm will take four placebo pills per day.
Experimental: 500 mg cocoa extract
Participants assigned to this arm will take two 250 mg cocoa extract pills per day and two placebo pills per day
Experimental: 1000 mg cocoa extract
Participants assigned to this arm will take four 250 mg cocoa extract pills per day
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: National Center for Complementary and Integrative Health (NCCIH)

This content was sourced from clinicaltrials.gov