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Study on the Effectiveness and Safety of BHV-7000 for Adults with Refractory Focal Onset Epilepsy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Refractory Focal Onset Epilepsy. This type of epilepsy is characterized by seizures that start in one area of the brain and are resistant to treatment with standard medications. The trial will evaluate a new treatment called BHV-7000, which is a prolonged-release tablet designed to be taken orally. The study will compare two different doses of BHV-7000 to a placebo to determine its effectiveness and safety in reducing the frequency of seizures in adults with this condition.

The purpose of the study is to see if BHV-7000 can help reduce the number of seizures experienced by participants. Participants will be randomly assigned to receive either one of the two doses of BHV-7000 or a placebo. The study will last for about 12 weeks, during which participants will take the medication daily and keep a record of their seizures. The goal is to find out if at least half of the participants experience a significant reduction in their seizure frequency.

Throughout the study, the safety and tolerability of BHV-7000 will be closely monitored. Participants will have regular check-ups to assess their health and any side effects they may experience. The study aims to provide valuable information on whether BHV-7000 can be a beneficial treatment option for those with Refractory Focal Onset Epilepsy.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the medication BHV-7000 or a placebo. The assignment is double-blind, meaning neither the participant nor the researchers will know which one is being administered.

    The medication is provided in the form of a prolonged-release tablet, which is taken orally.

  2. Step 2

    Treatment phase

    During the treatment phase, the participant will take the assigned tablet daily. The study aims to compare two different dose strengths of BHV-7000 with a placebo.

    The primary goal is to observe if there is at least a 50% reduction in the average number of seizures over a 28-day period.

  3. Step 3

    Monitoring and assessment

    Throughout the study, the participant's seizure frequency will be monitored using an electronic diary (eDiary). It is important to maintain accurate records, with no more than four missed entries over a 28-day period.

    The study will also assess safety by monitoring any adverse effects or changes in health status.

  4. Step 4

    Completion of the study

    The study is expected to conclude by August 18, 2025. At the end of the study, the data collected will be analyzed to determine the effectiveness and safety of BHV-7000 in reducing seizure frequency.

    Participants will be informed of the study results and any potential next steps regarding their treatment.

Who can join the trial?

11 criteria

  • Must provide a signed written informed consent, which means you agree to participate after understanding the study details.
  • You or your caregiver must be able to read and understand an electronic diary in a language that is available.
  • Must be able to swallow the BHV-7000 tablet whole.
  • Both males and females aged between 18 to 75 years can participate.
  • Must be able to keep accurate records of seizures and miss no more than 4 entries out of 28 days, showing at least 85% compliance with the electronic diary.
  • Must have been diagnosed with **Focal Onset Epilepsy** at least 1 year before the screening visit. This type of epilepsy starts in one area of the brain.
  • Must experience focal seizures, which can include:
    • Focal aware seizures with noticeable signs or symptoms.
    • Focal impaired awareness seizures with noticeable signs or symptoms.
    • Focal to bilateral tonic-clonic seizures, which start in one area and spread to both sides of the brain.
    • Must have **Drug Resistant Focal Onset Seizures**, meaning previous treatments did not stop the seizures. This is based on the 2009 definition by the International League Against Epilepsy (ILAE).
    • Currently using no more than 4 epilepsy treatments, with no more than 3 being anti-seizure medications (ASMs). Other treatments can include diet regimens or devices.

Who cannot join the trial?

5 criteria

  • Patients who do not have refractory focal onset epilepsy. This means the type of epilepsy that does not respond well to treatment and starts in one area of the brain.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are not considered part of a vulnerable population, which means groups that might need special protection or care.
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Investigated drugs

BHV-7000 is a medication being studied for its effectiveness in treating refractory focal onset epilepsy. This type of epilepsy is characterized by seizures that begin in one area of the brain and are resistant to standard treatments. The trial aims to determine if BHV-7000 can help reduce the frequency of seizures when used alongside other epilepsy medications.

What is already known about the treatment

BHV-7000 – BHV-7000 is administered orally and is currently being studied in clinical trials for its effectiveness in treating refractory focal onset epilepsy. It is in the Phase 2/3 stage of clinical trials, which means it is being tested for both efficacy and safety. The main therapeutic indication for BHV-7000 is to reduce the frequency of seizures in individuals with this type of epilepsy. At the molecular level, BHV-7000 works by modulating specific neurotransmitter pathways in the brain to stabilize neuronal activity and prevent seizures. It is classified pharmacologically as an antiepileptic drug.

Investigated diseases

Refractory Focal Onset Epilepsy – This is a type of epilepsy where seizures originate in a specific area of the brain and are resistant to standard treatments. Individuals with this condition experience focal seizures, which can affect motor, sensory, or autonomic functions, depending on the brain region involved. These seizures may or may not impair consciousness and can vary in duration and intensity. Over time, the frequency and severity of seizures can fluctuate, making management challenging. The condition is characterized by its persistence despite the use of multiple anti-seizure medications. It requires ongoing monitoring to assess changes in seizure patterns and potential impacts on daily life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508539-30-00Protocol codeBHV7000-302Estimated enrolment415 patientsSponsorBiohaven Therapeutics Ltd.

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