A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy (NCT06309966)

This is a phase 2/3, global, multicenter, randomised, double-blind, placebo-controlled, 3-arm study designed to assess the efficacy and safety of BHV-7000 in participants with refractory focal onset epilepsy who are stable with atleast 1 and upto 3 antiseizure medications. The goals of this study are to: . See how well BHV-7000 works to decrease the number of seizures the participant has in a month as compared to a placebo (tablet with no medication). . See if BHV-7000 is safe and tolerable.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Terence O'Brien

Key inclusion data

Inclusion Criteria Signed Written Informed Consent Subjects must agree to provide all requested demographic information (i.e., biological sex at birth, race, ethnicity (ethnicity collected in US only)). Subject and/ or caregiver must be able to read and understand eDiary in an available language. Exclusion Criteria 1. Target population a. Prisoners or subjects who are involuntarily incarcerated. b. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness. c. Any condition that may impact a subject’s ability to follow study procedures or subject’s safety, based on what is known about the pharmacology/toxicology profile of the trial agent(s). d. Participation in any other investigational clinical trial while participating in this clinical trial (including OP). 2. Target Disease Exclusion a. Non-focal seizures defined by ILAE criteria i. EEG shows any pattern not consistent with focal etiology of seizures (e.g., generalized spike-wave). ii. Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms. iii. Subjects with confirmed generalized onset seizures