Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy … (NCT06004388) | Clinical Trial Compass
CompletedPhase 3
Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)
United States110 participantsStarted 2023-07-21
Plain-language summary
Randomized study of two digital therapeutics for the prevention of episodic migraine in patients currently receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A participant will be eligible for entry into the study if all of the following criteria are met per participant self-report:
* Willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
* Lives in the United States.
* Adult or late adolescent, ≥ 18 years of age at the time of informed consent.
* Able to read and understand the English informed consent form.
* The following will be investigator-reviewed: Participant has at least a 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD), 3rd Edition:
i. Age of onset of migraines prior to 50 years of age
ii. Migraine attacks, on average, lasting 4-72 hours if untreated
iii. Per participant report, 4 or more migraine days per month within the last 3 months prior to the Screening Visit (a month is defined as 28 days)
iv. Four to fourteen migraine days during the run-in period
* Is currently managing migraines with at least 1 prescription CGRP inhibitor therapy for the preventive or acute treatment of episodic or chronic migraine during the 3 months prior to screening.
* Is the sole user of an iPhone with an iPhone operating system (iOS) 14 or later or a smartphone with an Android operating system (OS) 11 or later, and is willing to download and use the specified eDiary and Study App required by the prot…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.