A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy (NCT06443463)

This is a Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy and the goals of this study are to: • See if BHV-7000 is safe (assessing how many side effects you and others in this study have) and tolerable (how well you and others in this study tolerate any side effects) over 52 weeks. • See how well BHV-7000 works in reducing seizures; how often The study has 2 phases. • Long-term Treatment Phase: This phase will last for 52 weeks, and you will have 7 visits to the study site and will take the study drug every day. • Follow-up Phase: This phase will last for 2 weeks after your last dose of the study drug, and there will be 1 visit to the study site.

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 •Subjects and/or caregiver(s) and/or LAR(s) must be able to read and understand seizure recording instructions in an available language. •Subject must be able to swallow the BHV-7000 IP tablet whole. •Target Population a. Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303. b. Ability to complete all study procedures, measurements (including functional assessments) and visits. c. Females of childbearing potential (FOCBP) and fertile males with female partners who are FOCBP must agree to use 2 methods of contraception Exclusion Criteria •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, excluding parent studies BHV7000-302 or BHV7000-303. •Target Disease Exclusion a. In the opinion of the Investigator, and in discussion with the Medical Monitors, due to a change in seizure type or pattern, participation in the study would not be beneficial to the subject.