A Comparison of Rimegepant Orally Disintegrating Tablet (Nurtec ODT) to Rizatriptan Benzoate Orally Disintegrating Tablet (Maxalt MLT-ODT) in Adult Patients Presenting to the ED With Migraine Headache: Randomized, Double-Blind, Clinical Trial

This is a prospective, randomized, double-blind superiority trial evaluating and comparing analgesic efficacy and safety of Rimegepant ODT 75 mg to Rizatriptan ODT 10 mg in adult patients presenting to the ED of Maimonides Medical Center with acute migraine headache.

The investigators will conduct the study in the emergency department of Maimonides Medical Center, an urban emergency department that receives over 120,000 adult visits annually. The emergency department is staffed on weekdays by salaried, trained, bilingual (English and Spanish) research associates who execute research studies under the supervision of the principal investigators. Adult patients between ages of 18 and 65 presenting to the ED with an acute exacerbation of a migraine without aura as defined by the International Classification of Headache Disorders, 3rd edition criteria for migraine without aura or for probable migraine without aura, with an initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale, and requiring oral analgesia as determined by the treating attending physician will be eligible for participation. Subjects' screening and enrollment will be performed by study investigators and research assistants. All patients will be enrolled at various times of the day when study investigators will be available for patient enrollment and an ED pharmacist will be available for medication preparation.

Each patient will be approached by research associates for acquisition of written informed consent and Health Insurance Portability and Accountability Act authorization after being evaluated by the treating emergency physician and determined to meet study eligibility criteria. When English will not be the participant's primary language, a language- appropriate consent form will be used and non-investigator, hospital-employed, trained interpreters or licensed telephone interpreter will assist in acquisition of informed consent. Baseline pain score will be determined with an 11-point numeric rating scale (0 to 10), described to the patient as "no pain" being 0 and "the worst pain imaginable" being 10.

Research associates will ascertain the subject's headache level every 30 minutes after medication administration for up to 120 minutes. If enrolled subjects required more pain medication at or after one hour had elapsed, they will be given additional medication at the discretion of the treating physician.

The research team will be contacting all of research subjects by telephone 24 hours after ED discharge to ascertain headache status, satisfaction with treatment, and presence of adverse events.