Randomized Trial in Adult Subjects With Acute Migraines
Randomized Trial in Adult Subjects With Acute Migraines
The purpose of this study is to test the safety and efficacy of BHV-3500 versus placebo in
 the acute treatment of moderate or severe migraine.
Inclusion Criteria:

 1. Subject has at least 1-year history of migraines (with or without aura), consistent
 with a diagnosis according to the International Classification of

 Headache Disorder, 3rd Edition, including the following:

 1. Migraine attacks present for more than 1 year with the age of onset prior to 50
 years of age

 2. Migraine attacks, on average, lasting about 4-72 hours if untreated

 3. Not more than 8 attacks of moderate to severe intensity per month within the last
 3 months

 4. At least 2 consistent migraine headache attacks of moderate or severe intensity
 in each of the 3 months prior to the Screening Visit and maintains this
 requirement during the Screening period

 5. Less than 15 days with headache (migraine or non-migraine) per month in each of
 the 3 months prior to the Screening Visit and maintains this requirement during
 the Screening Period.

 6. Subjects on prophylactic migraine medication are permitted to remain on therapy
 provided they have been on a stable dose for at least 3 months prior to screening
 visit and the dose is not expected to change during the course of the study.

 7. Subjects with contraindications for use of triptans may be included provided they
 meet all other study entry criteria.

 2. Male and Female subjects ≥18 years of age.

 Exclusion Criteria:

 1. Subject with a history of HIV disease

 2. Subject history with current evidence of uncontrolled, unstable or recently diagnosed
 cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and
 cerebral ischemia. Subjects 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.

 3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however
 subjects can be included who have stable hypertension and/or diabetes for at least 3
 months prior to being enrolled).

 4. Subjects with major depressive episode within the last 12 months, major depressive
 disorder or any anxiety disorder requiring more than 1 medication for each disorder.

 5. Subject has a history of gastric, or small intestinal surgery (including Gastric
 Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has other disease
 or condition that causes malabsorption.

 6. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12
 months or subjects who have met DSM-V criteria for any significant substance use
 disorder within the past 12 months.

 7. History of nasal surgery in the 6 months.

 8. Evidence at screening of significant nasal conditions that may affect the
 administration or absorption of the nasal product (e.g. severe septum deviation, nasal
 deformity or blockage, inflammation, perforation, mucosal erosion or ulceration,
 polyposis, nasal trauma)

 9. Participation in any other investigational clinical trial while participating in this
 clinical trial.