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New treatment option for Migraine
Official title Cocoa Extract for Migraine Trial
ClinicalTrials.gov ID: NCT06808230
What this study is testing
- What it's testing
- 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?
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Individuals with self-reported migraine will need to report a clinician diagnosis of migraine and be classified as having migraine or probable...
- 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
You likely can't join if
- Self-reported history of stroke or transient ischemic attack; history of brain surgery or spine surgery; currently receiving treatment for a...
- Kidney failure or current dialysis treatment or any medical condition which the participant believes could lead to difficulty complying with the...
- 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
See the full eligibility 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...
- 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 assigned by chance to all treatment groups
- Be fluent in English
- Own an iPhone or Android device and be willing to download MyCap to the device
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.