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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 involves seizures that start in one area of the brain and are difficult to control with standard treatments. The study will test a new medication called BHV-7000, which is taken as a prolonged-release tablet. This means the medication is designed to release slowly into the body over time. The purpose of the study is to determine if BHV-7000 is effective and safe for adults with this type of epilepsy.

Participants in the study will be randomly assigned to receive either BHV-7000 or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for about eight weeks, during which participants will take the medication or placebo daily. Researchers will monitor the participants to see if there is a reduction in the number of seizures they experience. The goal is to find out if BHV-7000 can help reduce seizures by at least 50% in those taking the medication compared to those taking the placebo.

Throughout the study, the safety and tolerability of BHV-7000 will be closely observed. This means researchers will keep track of any side effects or adverse reactions participants might experience. The study aims to provide valuable information on whether BHV-7000 can be a beneficial treatment option for people with Refractory Focal Onset Epilepsy, potentially offering a new way to manage this challenging condition.

The research process

The trial runs in 6 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, eligibility is confirmed based on specific criteria, including age and diagnosis of refractory focal onset epilepsy.

    Participants must have a history of focal seizures and meet the definition of drug-resistant epilepsy.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish a baseline for seizure frequency and current treatment regimen.

    Participants are required to maintain accurate seizure diaries.

  3. Step 3

    Treatment phase

    Participants are randomly assigned to receive either BHV-7000 or a placebo.

    BHV-7000 is administered as a prolonged-release tablet taken orally.

    The study evaluates two dose strengths of BHV-7000.

  4. Step 4

    Double-blind period

    The double-blind period (DBP) lasts for 8 weeks.

    During this time, neither participants nor researchers know who receives BHV-7000 or the placebo.

    Seizure frequency is monitored and recorded throughout this period.

  5. Step 5

    Evaluation of results

    The primary goal is to determine if there is at least a 50% reduction in seizure frequency over 28 days compared to the observation period (OP).

    Secondary outcomes include changes in seizure frequency and overall improvement in condition.

  6. Step 6

    Safety assessment

    Safety is evaluated by monitoring adverse events, including any serious adverse events (SAEs) and laboratory abnormalities.

    The study aims to ensure the treatment is both effective and safe for participants.

Who can join the trial?

7 criteria

  • Participants must be **male or female** and between **18 to 75 years old** at the time they agree to join the study.
  • Participants must have been diagnosed with **Focal Onset Epilepsy** for at least **1 year** before the screening visit. This type of epilepsy includes:
    • **Focal aware seizures**: Seizures where the person is aware and has noticeable signs or symptoms.
    • **Focal impaired awareness seizures**: Seizures where the person has noticeable signs or symptoms but is not fully aware.
    • **Focal to bilateral tonic-clonic seizures**: Seizures that start in one part of the brain and spread to both sides, causing convulsions.
    • Participants must meet the definition of **drug-resistant epilepsy**. This means they have tried at least **two different anti-seizure medications** that were suitable and used correctly, but these did not stop the seizures.
    • Participants must be able to **keep accurate seizure diaries**, which means they can record their seizures correctly.
    • Participants must currently be taking at least **1 and up to 3 anti-seizure medications** and a total of **4 epilepsy treatments**. This can include medications, diet changes, or devices.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of epilepsy that is not refractory focal onset epilepsy. This means their seizures do not start in one specific area of the brain and are not resistant to treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the effects of the study medication on unborn babies or infants are not known.
  • Patients who are currently participating in another clinical trial or have recently participated in one.
  • Patients who have a history of drug or alcohol abuse, which might affect their ability to follow the study requirements.
  • Patients who have allergies or reactions to the study medication or similar types of medications.
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Investigated drugs

BHV-7000 is being studied as an additional treatment for people with refractory focal onset epilepsy. This means it is used alongside other epilepsy medications to help reduce the number of seizures. The trial aims to see if this medication can help decrease seizures by at least 50% in a month for those who have not responded well to other treatments.

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, indicating that it is being evaluated 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, and may or may not involve a loss of consciousness. The seizures can vary in frequency and intensity, often disrupting daily activities. Over time, the condition may lead to changes in brain function due to repeated seizure activity. Managing this type of epilepsy can be challenging, as it does not respond well to typical anti-seizure medications. The focus is often on finding alternative therapies to reduce seizure frequency and improve quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-508811-21-00Protocol codeBHV7000-303Estimated enrolment396 patientsSponsorBiohaven Therapeutics Ltd.

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