Study of BHV-7000 for Refractory Focal Onset Epilepsy
This study is investigating if BHV-7000 is an effective and safe treatment for adults with refractory focal onset epilepsy (seizures that start in one area of the brain and are difficult to control with current medications). Participants will receive either BHV-7000 at different doses (25 mg, 50 mg, or 75 mg) or a placebo (an inactive substance that looks like the study drug) once daily. The study will look at how often seizures occur and any side effects experienced. Adults aged 18 to 75 years with a diagnosis of focal onset epilepsy for at least one year may be eligible to participate. The goal is to see if BHV-7000 can reduce seizure frequency.
- Study design
- This is an interventional study with an estimated enrollment of 390 participants. It has two parts, A and B, where participants are randomly assigned to receive different doses of BHV-7000 or a matching placebo.
- What's involved
- Participants will take a blinded investigational product (BHV-7000 or placebo) once daily. The study measures seizure frequency and monitors for side effects and laboratory abnormalities for at least 8 to 20 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for deaths, serious adverse events, and other side effects from Week 8 to Week 20 of each study part.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
At a glance
Conditions
Where it's being run
124 sites across 69 statesWho to contact
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What this trial measures
- Part B: Change from Baseline in 28-day average seizure frequencyBaseline, Week 8 to Week 20 of Part B
To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 12-week double-blind treatment phase.
- Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEsWeek 8 to Week 20 of Part A
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
- Part A: Number of Participants With Clinically Significant Laboratory AbnormalitiesWeek 8 to Week 20 of Part A
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.