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NCT07125261 · ClinicalTrials.gov registry record · Phase 1
BHV-7000 Responsive Neurostimulation System (RNS) Study
A Phase 1 study of Epilepsy and Seizures, sponsored by Yale University.
- Active
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT07125261: Active Phase 1 study of Epilepsy and Seizures, sponsored by Yale University.
NCT07125261 is a Phase 1 study of Epilepsy and Seizures that is active but no longer recruiting, run by Yale University. The registered enrollment target is 5 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07125261, a Phase 1 study of Epilepsy and Seizures, is active but no longer recruiting, sponsored by Yale University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Per-participant percentage reduction in patient-specific seizure surrogate rate in the treatment period relative to retrospective baseline.
Interventions
- DRUG BHV-700
Study Locations (1)
Connecticut
- Yale Comprehensive Epilepsy Center - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2025-10-07 |
| Est. Completion | 2026-09 |
| Phase | Phase 1 |
What the registry record for NCT07125261 still lists
NCT07125261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which BHV-700 is the first listed.
NCT07125261 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT07125261 about?
NCT07125261 is a clinical study titled "BHV-7000 Responsive Neurostimulation System (RNS) Study". 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 ...
What is the current status of trial NCT07125261?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2025-10-07. Estimated completion is 2026-09.
What conditions does trial NCT07125261 study?
This clinical trial studies the following conditions: Epilepsy, Seizures.
What interventions are being tested in trial NCT07125261?
The interventions under investigation include: BHV-700 (DRUG).
Who is sponsoring clinical trial NCT07125261?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07125261 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07125261's enrollment target sits among peer trials
5 156th of 160 higher than 2 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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