Clinical Trial

BHV-7000 Responsive Neurostimulation System (RNS) Study

Active, Not Recruiting Phase 1
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Summary
This is an open label study to assess the biological effect of BHV-7000 on abnormal activity recorded by the RNS System in patients with focal epilepsy implanted with the RNS System. BHV-7000 is a potassium channel activator being evaluated for use in epilepsy. Participants are offered the drug for 4 weeks. Activity during that treatment period is compared to a 90-day retrospective baseline period in which other medications and device settings were stable, and also to a 4-week withdrawal period after treatment is discontinued. The study is open to patients with RNS regardless of whether they report clinical seizures, as long as the device recordings continue to show epileptiform activity.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-08-08; most recent amendment 2026-06-10.
Status change: Recruiting → Active, Not Recruiting 2026-03-05
Status change: Not Yet Recruiting → Recruiting 2025-10-30
Trial Details
NCT Number NCT07125261
Lead Sponsor Yale University
Collaborators: Biohaven Pharmaceuticals, Inc.
Conditions Epilepsy, Seizures
Enrollment 5 participants
Start Date 2025-10-07
Primary Completion 2026-03-18 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-12