Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US

Inclusion Criteria:

• Patients with at least 1 year history of episodic migraine (with or without aura)consistent with a diagnosis according to the International Classification ofHeadache Disorders-3 (ICHD-3)

• Men and women ≥ 18 years old .

• Average of 2-8 migraine attacks of moderate or severe intensity per month within thelast 3 months prior to the screening visit

• Headache/migraine onset before age 50 years

• Migraine attacks, on average, lasting 4-72 hours if untreated

• At least 48 hours between migraine attacks

• Ability to distinguish migraine attacks from tension or cluster headaches

• Particpants on SOC treatment should be on stable regimen for at least 3 months priorto enrollment and should not change their regimen during the course of the study

• Participant may have been on treatment with Botox or mAbs for the last 6 months

• Participants experience migraine ≥75% of the time following exposure to a triggerduring the run-in period. Acceptable triggers include exercise, alcohol ( less thanone drink per day for woman and less than two drinks per day for men), air travelthat lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or weekend/ let-down

Exclusion Criteria:

• Using gepants as preventive treatment (atogepant once daily (QD) or rimegepant everyother day (EOD)), or using zavegepant or ubrogepant as an acute treatment

• History of use of narcotic or barbiturate containing medications, including opioids (e.g., morphine, codeine, oxycodone, and hydrocodone) on ≥5 days per month on aregular basis for ≥3 months prior to screening

• Current evidence of uncontrolled, unstable, or recently diagnosed cardiovasculardisease, uncontrolled hypertension, or uncontrolled diabetes.

• Current diagnosis of major depressive disorder requiring treatment with atypicalantipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder.

• Women must not be pregnant, lactating or breastfeeding