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 range18 Years
SexALL
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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…