Study of BHV-7000 for Adults with Refractory Focal Onset Epilepsy
This study is testing a new medication called BHV-7000 to see if it is safe and effective for adults with refractory focal onset epilepsy. Refractory focal onset epilepsy means you have seizures that start in one area of the brain and haven't responded well to other treatments. Participants will receive either BHV-7000 at two different doses (50 mg or 75 mg) or a placebo (an inactive substance that looks like the study drug). The main goal is to see how much the average number of seizures changes over 28 days, comparing the beginning of the study to weeks 8 through 16. You may be able to join if you are between 18 and 75 years old and have been diagnosed with focal onset epilepsy for at least one year. The study plans to enroll about 390 people, but its current recruitment status is unclear.
- Study design
- This is an interventional study where participants will take a blinded investigational product (BHV-7000 or placebo) once daily. The study plans to enroll 390 participants.
- What's involved
- Participants will take a blinded investigational product once daily. The primary endpoint measures seizure frequency from baseline to weeks 8-16.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome measures changes in seizure frequency up to Week 16 after starting the study treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
150 sites across 71 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Change from Baseline in 28-day average seizure frequencyBaseline, Week 8 to Week 16
To compare the efficacy of 75mg 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 8-week double-blind treatment phase.