Summary:
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.
Criteria: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:
- Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
- Migraine attacks, on average, lasting about 4-72 hours if untreated
- Not more than 8 attacks of moderate to severe intensity per month within the last 3 months
- 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
- 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.
- 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.
- Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.
- Male and Female subjects ≥18 years of age.
Qualified Participants May Receive:
Compensation up to $550.00 over the study length (11 weeks).