OnSite Clinical Solutions LLC | Charlotte, NC
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About
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Male and Female participants 18 to 75 years of age at time of consent.
Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.
a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures iii. Focal to bilateral tonic-clonic seizures
Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
Ability to keep accurate seizure diaries
Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.)
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
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390 participants in 3 patient groups, including a placebo group
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Chief Medical Officer
Data sourced from clinicaltrials.gov
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