BHV-7000 Responsive Neurostimulation System (RNS) Study

NCT07125261 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 2000039852
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy; Seizures

Keywords

neurostimulation; antiseizure medication; RNS

Outcome Measures

Primary Outcomes (4)

• Reduction in patient-specific seizure surrogate rate

  Per-participant percentage reduction in patient-specific seizure surrogate rate in the treatment period relative to retrospective baseline.

  28 days

• Reduction in seizure onset pattern rate

  Per-participant percentage reduction in seizure onset pattern rate in the treatment period relative to retrospective baseline.

  28 days

• Reduction in long episode rate

  Per-participant reduction in long episode rate during the treatment period relative to the retrospective baseline.

  28 days

• Reduction in saturation rate

  Per-participant reduction in saturation rate during the treatment period relative to the retrospective baseline, for those patients who have saturations.

  28 days

Secondary Outcomes (4)

• Withdrawal effect on patient-specific seizure surrogate rate

  4 weeks post 28-day treatment

• Withdrawal effect on seizure onset pattern rate

  4 weeks post 28-day treatment

• Withdrawal effect on long episode rate

  4 weeks post 28-day treatment

• Number of Participants With Treatment-Related Laboratory Abnormalities or Adverse Events of Special Interest (AESI) as Assessed by CTCAE/DAIDS

  up to 12 weeks

Study Arms (1)

BHV-7000

EXPERIMENTAL

Participants will receive up to 28 days of study drug and will be followed clinically until Day 56, making their total involvement in the study up to 84 days. The study follows an ABA treatment paradigm with (A) 90-day retrospective RNS baseline, (B) 4-week treatment period, and (A) 4-week withdrawal period.

Drug: BHV-700

Interventions

BHV-700 DRUG

75 mg daily for the 4-week treatment period (dose which may be adjusted based on tolerability)

BHV-7000

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of focal epilepsy as documented in the medical record.
• Implanted at least 1 year ago with RNS.
• RNS device actively recording intracranial EEG data.
• Baseline RNS recordings show that the over 50% of detections represent epileptiform seizure onset patterns.
• Provision of signed and dated informed consent form.
• Ability to take oral medication and be willing to adhere to the BHV-7000 treatment regimen.
• Body mass index (BMI) \< 40 kg/m² at screening visit.

You may not qualify if:

• Change in any antiseizure medication (including addition or discontinuation of any antiseizure
• Any change in RNS detection settings within 90 days prior to planned treatment Day 1.
• Change in RNS stimulation settings within 90 days prior to planned drug administration (retrospective baseline period).
• Poor or inconsistent history of device downloads in the 90 days prior to planned treatment Day 1, as determined by less than 90% of episode start data being available at treatment Day 1.
• RNS battery low (estimated to last for less than 3 months).
• Schizophrenia and other psychotic disorders (e.g., schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified \[NOS\]), bipolar disorder, and/or obsessive-compulsive disorder, or other serious mental health disorders. Uncontrolled unipolar major depression where changes in pharmacotherapy are needed or anticipated during the study.
• Active suicidal plan/intent in the past six months, a suicide attempt in the last two years, or more than one lifetime suicide attempt.
• History of illicit drug or alcohol abuse within one year prior to screening judged by the PI to be excessive or compulsive, or currently using drugs of abuse or any prescribed or over the counter medication in a manner that the PI considers indicative of abuse or dependence.
• History of cancer within the past two years, with the exception of appropriately treated basal cell or squamous cell carcinoma.
• History of clinically significant urinary retention in the judgment of the PI.
• Previous exposure to BHV-7000 or known allergy to BHV-7000 or its excipients.
• Any major surgery within one month or an acute illness within two weeks prior to screening.
• Vaccination within the previous four weeks prior to screening or planned vaccination during the study.
• History of ezogabine use.
• Known allergic reactions to components of the study drug.

Sponsors & Collaborators

• Yale University: lead
• Biohaven Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Yale Comprehensive Epilepsy Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Imran Quraishi, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Model Details: The study population includes adults with focal epilepsy who have been implanted with RNS and continue to have epileptiform activity in their RNS device recordings.

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 15, 2025
• Study Start: October 7, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)