BHV-7000 for Epilepsy

Overseen By Imran Quraishi, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Must not be taking: CYP3A4 inhibitors, inducers

Disqualifiers: Schizophrenia, Bipolar, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, BHV-7000, for individuals with focal epilepsy who have an implanted RNS System device that records brain activity. Researchers aim to observe how this drug affects abnormal brain activity linked to seizures. Participants will take the drug for four weeks, and their brain activity will be compared to periods before and after treatment. Those with an RNS device for over a year and recordings showing seizure patterns might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that there be no changes in any antiseizure medication for 90 days before starting the trial. This suggests you should continue your current medications without changes during that time.

Is there any evidence suggesting that BHV-7000 is likely to be safe for humans?

Research has shown that BHV-7000 is safe and easy to handle. In studies, participants took up to 120 mg daily for 15 days without major issues. This dosage exceeds what might be used in other treatments. Importantly, users did not experience the usual side effects seen with other epilepsy drugs. This suggests that BHV-7000 could be a gentler option for people with epilepsy. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BHV-7000 is unique because it represents a novel approach to treating epilepsy by potentially offering a new mechanism of action. While most epilepsy treatments work by modulating neurotransmitters like GABA or blocking sodium channels to prevent seizures, BHV-7000 might offer a different pathway. Researchers are excited about its potential to act more precisely on specific seizure pathways, which could lead to fewer side effects and improved efficacy compared to current medications. This innovative angle could provide new hope for patients who haven't found success with existing treatments.

What evidence suggests that BHV-7000 might be an effective treatment for epilepsy?

Research has shown that BHV-7000, the treatment under study in this trial, could be a promising option for epilepsy. It works by opening potassium channels, calming overactive brain cells. Early studies found that BHV-7000 is safe and well-tolerated, lacking the usual side effects of other seizure medications. Patients reported satisfaction with the treatment, noting improved mental clarity and fewer severe seizures. While more research is needed, these early findings suggest that BHV-7000 could effectively manage focal epilepsy. ^{1 2 4 5 6}

Who Is on the Research Team?

Imran Quraishi, MD, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for individuals with focal epilepsy who have had an RNS System implanted for at least a year. They must show epileptiform seizure patterns in over half of their RNS detections, have a BMI under 40 kg/m², and be able to take oral medication. Women of childbearing potential and fertile men must agree to use effective contraception methods during the study.

Inclusion Criteria

Implanted at least 1 year ago with RNS

I have been diagnosed with focal epilepsy.

Body mass index (BMI) < 40 kg/m² at screening visit

Exclusion Criteria

Known allergic reactions to components of the study drug

Presence of any retinal abnormality on baseline ophthalmic examination

I have had serious issues with not being able to empty my bladder fully.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

90-day retrospective baseline period with stable medications and device settings

12 weeks

Treatment

Participants receive BHV-7000 for 4 weeks to assess its effect on epileptiform activity

4 weeks

Withdrawal

4-week period after treatment discontinuation to assess withdrawal effects

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BHV-7000

Trial Overview The BHV-7000 Responsive Neurostimulation System (RNS) Study tests the effect of BHV-7000, a potassium channel activator on abnormal brain activity in epilepsy patients with an RNS implant. The drug's impact during treatment is compared against baseline activity and after withdrawal.

How Is the Trial Designed?

Group I: BHV-7000 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Biohaven Pharmaceuticals, Inc.

Industry Sponsor

Trials

49

Recruited

30,100+

Citations

1. neurology.org neurology.org/doi/10.1212/WNL.0000000000206409

Phase 1 Study Evaluating the Safety and Tolerability of ... Conclusions: BHV-7000 was safe and well tolerated, without the typical AEs associated with other anti-seizure medications. These findings ...

2. ir.biohaven.com ir.biohaven.com/news-releases/news-release-details/biohaven-presents-new-data-bhv-7000-once-daily-extended-release

Biohaven Presents New Data with BHV-7000 Once-Daily ... Reported expanded safety results from BHV-7000 Phase 1 multiple ascending dose studies, including the once-daily extended-release formulation being evaluated ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06132893

NCT06132893 | A Study to Determine if BHV-7000 is ... To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP ...

4. aesnet.org aesnet.org/abstractslisting/a-first-in-human-phase-1-study-evaluating-the-safety-and-tolerability-of-bhv-7000-a-novel-selective-kv7-2-7-3-potassium-channel-activator-in-healthy-adults

Abstracts - American Epilepsy Society Patients reported satisfaction with treatment and improved cognitive effects after seizures and seizure severity.

5. prnewswire.com prnewswire.com/news-releases/biohaven-presents-new-data-with-bhv-7000-once-daily-extended-release-formulation-demonstrating-excellent-safety-profile-and-nonclinical-data-updates-at-american-epilepsy-society-2024-annual-meeting-302324613.html

Biohaven Presents New Data with BHV-7000 Once-Daily ... Reported expanded safety results from BHV-7000 Phase 1 multiple ascending dose studies, including the once-daily extended-release formulation ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06443463

Long-term Safety and Tolerability of BHV-7000 A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset ...