Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)

Inclusion Criteria:

• A participant will be eligible for entry into the study if all of the followingcriteria 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-yearhistory of migraine (with or without aura) consistent with a diagnosis according tothe 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 therapyfor the preventive or acute treatment of episodic or chronic migraine during the 3months prior to screening.

• Is the sole user of an iPhone with an iPhone operating system (iOS) 14 or later or asmartphone with an Android operating system (OS) 11 or later, and is willing todownload and use the specified eDiary and Study App required by the protocol.

• Is willing and able to receive SMS text messages and push messages on theirsmartphone.

• Is the owner of, and has regular access to, an email address.

• Has regular access to the Internet via cellular data plan and/or wifi.

• Understands the use of and interest in the eDiary and the Study App during thescreening period and the baseline visit (Day 1).

Exclusion Criteria:

• A participant will not be eligible for study entry if any of the following criteriaare met per participant self-report:

• History of basilar migraine or hemiplegic migraine.

• Active chronic pain syndromes, such as fibromyalgia, chronic pelvic pain, or complexregional pain syndrome (CRPS).

• Other pain syndromes (including trigeminal neuralgia), psychiatric conditions (suchas current major depressive episode, bipolar disorder, major depressive disorder,schizophrenia), dementia, or significant neurological disorders (other thanmigraine) that, in the Investigator's opinion, might interfere with studyassessments.

• History of, treatment for, or evidence of, alcohol or drug abuse within the past 12months (48 weeks) or having met DSM-5 criteria for any significant substance usedisorder within the past 12 months (48 weeks) from the date of the screening visit.

• History of use of analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs] oracetaminophen, including opioids) or butalbital on ≥ 15 days per month during the 3months (12 weeks) prior to the Screening Visit or during the run-in period.

• Post-traumatic headache, persistent post-traumatic headache, or post-concussionsyndrome.

• Other significant acute or chronic medical condition(s) that, in the opinion of theInvestigator, may confound the interpretation of findings to inform PDT development.

• Failure to adhere with or inability to complete eDiary inputs and onboardingactivities during the run-in period. Participants who are not adherent during therun-in period are not eligible for study entry.

• Previous enrollment in any digital therapeutics pilot or pivotal study for amigraine indication.

• Participation in any other investigational clinical study