Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine

Key Inclusion Criteria:

Participants with at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition,19 including the following:

1. 2-8 migraine headache attacks of moderate or severe intensity in each of the 3months prior to the Screening Visit and throughout the Screening Period.

2. Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Period.

3. Participants on prophylactic migraine medication are permitted to remain on therapythey have been on a stable dose for at least 3 months prior to the Screening Visit.

Key Exclusion Criteria:

1. Participants with a history of basilar migraine or hemiplegic migraine.

2. Participants who have taken medication for acute treatment of headache (includingtriptans, ergotamine, opioids, acetaminophen, NSAIDs, or combination analgesics) on 10 or more days in any of the 3 months prior to screening.

3. Participants who have used a neuromodulation device for migraine treatment over thepreceding 3 months before screening.

4. History of chronic active infection (e.g., HIV, hepatitis B or C, tuberculosis,etc.), or individuals who have received anti-HCV treatment within 6 months prior toScreening.

5. Participant history with current evidence of uncontrolled, unstable or recentlydiagnosed cardiovascular disease, such as ischemic heart disease, coronary arteryvasospasm, and cerebral ischemia. participants with Myocardial Infarction (MI),Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiacsurgery, stroke or transient ischemic attack (TIA) during the 6 months prior toscreening.

6. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however,participants can be included who have stable hypertension and/or stable diabetes forat least 3 months prior to being enrolled). A single blood pressure measurement ofgreater than 150 mm Hg systolic or 100 mm Hg diastolic after 10 minutes of rest isexclusionary.

7. Participant has a current diagnosis of major depression, other pain syndromes (e.g.chronic pelvic pain, chronic regional pain syndrome, fibromyalgia), psychiatricconditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere withstudy assessments.

8. Participant has a history of gastric, or small intestinal surgery (including gastricbypass, gastric banding, gastric sleeve, gastric balloon, etc.), or other disease orcondition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causesmalabsorption.

9. Participant is on or has a recent history (past 30 days) of concomitant use ofmoderate/strong CYP3A4 inhibitors or inducers.

10. Participant is on or has a recent history (past 30 days) of concomitant use ofmoderate/strong p-gp or BCRP inhibitors.