drugset / Trial / NCT07125261

BHV-7000 Responsive Neurostimulation System (RNS) Study

NCT07125261 ↗

Phase 1 Active not recruiting 5 enrolled Yale University Biohaven Pharmaceuticals, Inc. · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-10-07
Primary completion
2026-03-18
Completion
2026-09

Drugs

EvaluationDrugModalityDoseRoute
Subject BHV-700 Unknown 75 mg —

Indications