Table 1 Summary of inclusion and exclusion criteria for BHV3500-301

Inclusion criteria

 · Adults aged ≥ 18 years

 · ≥ 1 year history of migraine with age of onset prior to 50 years of age, with or without aura, and consistent with a diagnosis according to the ICHD-3 Beta Edition

 · Migraine attacks lasting, on average, about 4 to 72-hours if untreated

 · 2 to 8 moderate to severe monthly migraine attacks; < 15 MHDs (migraine or nonmigraine) over the last 3 months

 · Use of preventive migraine medication permitted if stable for ≥ 3 months prior to screening visit; however, the use of CGRP mAb therapy was not permitted

 · Participants with any contraindications for use of triptans were included provided they met all other study criteria

Exclusion criteria

 · History of human immunodeficiency virus disease

 · Current evidence of uncontrolled, unstable, or recently diagnosed CV, and cardiac surgery,

 · stroke, or transient ischemic attack during 6 months prior to screening

 · Uncontrolled hypertension or uncontrolled diabetes

 · Current diagnosis of major depression, other pain syndromes, psychiatric conditions, or significant neurological disorders other than migraine

 · History of gastric or small intestinal surgery, or disease-causing malabsorption

 · Drug or alcohol abuse within 12 months prior to screening visit

 · History of nasal surgery 6 months preceding screening visit

 · Participation in any other investigational clinical trial while participating in this clinical trial