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

Phase 2 Double-Blind, Randomized, Placebo Controlled, Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine

This study is designed to identify at least one dose of BHV-2100 that is safe and effective in reducing headache pain and other symptoms in the 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 3 months 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 therapy they 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 (including triptans, 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 the preceding 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 to Screening.
5. Participant history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. participants with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
6. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however, participants can be included who have stable hypertension and/or stable diabetes for at least 3 months prior to being enrolled). A single blood pressure measurement of greater than 150 mm Hg systolic or 100 mm Hg diastolic after 10 minutes of rest is exclusionary.
7. Participant has a current diagnosis of major depression, other pain syndromes (e.g. chronic pelvic pain, chronic regional pain syndrome, fibromyalgia), psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments.
8. Participant has a history of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etc.), or other disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption.
9. Participant is on or has a recent history (past 30 days) of concomitant use of moderate/strong CYP3A4 inhibitors or inducers.
10. Participant is on or has a recent history (past 30 days) of concomitant use of moderate/strong p-gp or BCRP inhibitors.