EpilepsyPhase 1NCT07125261
BHV-7000 Responsive Neurostimulation System (RNS) Study
A Phase 1 study testing BHV-700 in people with Epilepsy and Seizures, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- BHV-700
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2025to 16 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
- Febrile illness within 90 days prior to planned treatment Day 1.
- Significant cardiovascular history, including but not limited to uncontrolled angina, myocardial infarction (Ml) within 12 months of screening, clinically significant arrhythmia, congestive heart failure (New York Heart Association [NYHA] Class Ill or higher).
- QTcF (Fridericia) interval 450 msec for males and 470 msec for females; Mobitz Type II second or third degree atrioventricular (AV) block, or complete left bundle branch block, or complete right bundle branch block, or intraventricular conduction defect with a QRS duration 130 msec, or evidence of acute or sub-acute myocardial infarction (Ml) or ischemia, or other ECG findings that, in the investigator's opinion, would preclude participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Comprehensive Epilepsy Center
New Haven, Connecticut, 06520
About this study
Official title: BHV-7000 Efficacy Against Epileptiform Activity in Patients With Epilepsy Implanted With RNS
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.
Read the detailed description
This is an open-label proof-of-principle study to assess the biological effect BHV-7000 on epileptiform activity detected by the RNS System. The study uses a single case experimental design in a small number of participants. Following a 90-day retrospective baseline period, there is a 4-week treatment period followed by a 4-week withdrawal period. Objective electrophysiologic biomarkers will be obtained from patients' RNS and analyzed in each participant to assess patient-level efficacy.
The primary objective of this study is to determine whether BHV-7000, a potassium channel activator, reduces the frequency of electrographic biomarkers of epileptic activity detected in patients with epilepsy who were implanted with the RNS System.
Secondary objectives are assess whether BHV-7000 withdrawal in participants leads to subsequent worsening of electrographic biomarkers of seizures compared to the treatment period, and to assess the safety and tolerability of BHV-7000 in participants with epilepsy who have been implanted with RNS.
- Being tested
- BHV-700
- Keywords
- neurostimulation, antiseizure medication, RNS
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHV-700Drug
75 mg daily for the 4-week treatment period (dose which may be adjusted based on tolerability)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BHV-700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28 days
Reduction in long episode rate
Per-participant reduction in long episode rate during the treatment period relative to the retrospective baseline.
Measured: 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.
Measured: 28 days
Secondary outcomes (4)
Withdrawal effect on patient-specific seizure surrogate rate
Change in patient-specific seizure surrogate rate following drug withdrawal.
Measured: 4 weeks post 28-day treatment
Withdrawal effect on seizure onset pattern rate
Change in seizure onset pattern rate following drug withdrawal.
Measured: 4 weeks post 28-day treatment
Withdrawal effect on long episode rate
Change in long episode rate following drug withdrawal.
Measured: 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
Treatment-emergent laboratory abnormalities and AESIs will be reported. Higher score corresponding to increasing AE severity.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start7 Oct 2025
- Primary completion18 Mar 2026
- Study completion16 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Biohaven Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Imran Quraishi, Yale University
- Investigators
- Imran Quraishi, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125261
- Sponsor's protocol ID
- 2000039852
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BHV-7000 Efficacy Against Epileptiform Activity in Patients With Epilepsy Implanted With RNS
- ClinicalTrials.gov ID
- NCT07125261
- Acronym / sponsor ID
- 2000039852
- Keywords
- neurostimulation, antiseizure medication, RNS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Biohaven Pharmaceuticals, Inc.
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 16 Sep 2026 (actual)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label proof-of-principle study to assess the biological effect BHV-7000 on epileptiform activity detected by the RNS System. The study uses a single case experimental design in a small number of participants. Following a 90-day retrospective baseline period, there is a 4-week treatment period followed by a 4-week withdrawal period. Objective electrophysiologic biomarkers will be obtained from patients' RNS and analyzed in each participant to assess patient-level efficacy.
The primary objective of this study is to determine whether BHV-7000, a potassium channel activator, reduces the frequency of electrographic biomarkers of epileptic activity detected in patients with epilepsy who were implanted with the RNS System.
Secondary objectives are assess whether BHV-7000 withdrawal in participants leads to subsequent worsening of electrographic biomarkers of seizures compared to the treatment period, and to assess the safety and tolerability of BHV-7000 in participants with epilepsy who have been implanted with RNS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| BHV-7000 | Experimental | Drug: BHV-700Participants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHV-70075 mg daily for the 4-week treatment period (dose which may be adjusted based on tolerability) | Drug | BHV-7000 |
Primary outcome
Reduction in patient-specific seizure surrogate rate
Time frame: 28 days
Per-participant percentage reduction in patient-specific seizure surrogate rate in the treatment period relative to retrospective baseline.
Reduction in seizure onset pattern rate
Time frame: 28 days
Per-participant percentage reduction in seizure onset pattern rate in the treatment period relative to retrospective baseline.
Reduction in long episode rate
Time frame: 28 days
Per-participant reduction in long episode rate during the treatment period relative to the retrospective baseline.
Reduction in saturation rate
Time frame: 28 days
Per-participant reduction in saturation rate during the treatment period relative to the retrospective baseline, for those patients who have saturations.
4 secondary outcomes
Withdrawal effect on patient-specific seizure surrogate rate
Time frame: 4 weeks post 28-day treatment
Withdrawal effect on seizure onset pattern rate
Time frame: 4 weeks post 28-day treatment
Withdrawal effect on long episode rate
Time frame: 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
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
Enrolling by invitation
An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy
Epilepsy
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Enrolling by invitationObservational study
Neurophysiological Intraoperative or Epilepsy Monitoring
Patients Operated on at the Neurosurgery Department
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imran Quraishi, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BHV-700 in people with Epilepsy and Seizures, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in patient-specific seizure surrogate rate (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.