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Study on BHV-7000 for Patients with Generalized Tonic-clonic Seizures in Idiopathic Generalized Epilepsy

Fast replyInvestigationalNo placebo
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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 Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures. The trial will evaluate a treatment called BHV-7000, which is a prolonged-release tablet developed by Biohaven Therapeutics Ltd. The purpose of the study is to compare the effectiveness of BHV-7000 to a placebo when used as an additional therapy for people with this type of epilepsy.

Participants in the study will receive either the BHV-7000 tablet or a placebo. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. The trial will include an open-label extension, which means that after the initial phase, all participants may have the opportunity to receive BHV-7000 if they choose to continue. The study will last for a period of up to 72 weeks.

The main goal is to observe the time it takes for participants to experience a second day with a generalized tonic-clonic seizure during the double-blind phase. Additionally, the study will assess the safety and tolerability of BHV-7000 by monitoring any side effects or adverse events that occur. This trial aims to provide valuable information on the potential benefits and risks of using BHV-7000 as a treatment option for individuals with this form of epilepsy.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing the diagnosis of idiopathic generalized epilepsy with generalized tonic-clonic seizures and ensuring the participant meets the criteria for drug-resistant epilepsy.

  2. Step 2

    Double-blind phase

    Participants are randomly assigned to receive either the study medication BHV-7000 or a placebo. Both are administered as prolonged-release tablets taken orally.

    The primary goal during this phase is to measure the time to the second day with a generalized tonic-clonic seizure. The duration of this phase is 24 weeks.

  3. Step 3

    Medication administration

    Participants take the assigned medication daily. The dosage and specific instructions are provided by the study team and must be followed precisely.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, participants are monitored for seizure activity and any side effects. This includes regular visits to the study site for assessments and to ensure safety and tolerability of the treatment.

  5. Step 5

    Open-label extension

    After completing the double-blind phase, participants may enter an open-label extension where all receive BHV-7000. This phase allows for continued monitoring of efficacy and safety.

  6. Step 6

    Study completion

    The study is estimated to conclude by November 2027. Final evaluations are conducted to assess the overall outcomes and any long-term effects of the treatment.

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 need to have been diagnosed with **Idiopathic Generalized Epilepsy (IGE)** for at least **6 months** before the screening visit. This diagnosis should follow the guidelines set by the **2017 International League Against Epilepsy (ILAE)**.
  • Participants should have **generalized tonic-clonic (GTC) seizures** as part of their IGE. This means they have GTC seizures and specific patterns on an **electroencephalogram (EEG)**, which is a test that measures brain activity. They should not have any focal abnormalities, which means no unusual activity in a specific part of the brain.
  • Participants should meet the **2009 ILAE definition of drug-resistant epilepsy**. This means they have tried at least two different anti-seizure medications, either alone or together, but these have not successfully stopped their seizures.
  • Participants or their caregivers must be able to keep **accurate seizure diaries**, which are records of when seizures happen.
  • Participants should currently be on treatment with **1 to 3 anti-seizure medications (ASMs)**, and they can have up to 4 different epilepsy treatments in total. This could include medications, a special diet, or a device.
  • Participants need to have a history of having at least **3 days with a GTC seizure** spread out over the **16 weeks** before the screening visit. This means they should have had at least one day with a GTC seizure in the first 8 weeks and at least one day with a GTC seizure in the second 8 weeks.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of epilepsy than Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures. This means if your seizures are not of this specific type, you cannot participate.
  • Patients who are not within the specified age range for the study. The study has specific age requirements, so if you are too young or too old, you may not be eligible.
  • Patients who are not able to follow the study procedures or take the study medication as required. This means if you have difficulty understanding or following the study rules, you might not be able to join.
  • Patients who have other medical conditions that might interfere with the study. If you have other health issues that could affect the study results, you may not be allowed to participate.
  • Patients who are pregnant or breastfeeding. If you are expecting a baby or nursing, you cannot take part in the study.
  • Patients who are currently participating in another clinical trial. If you are already involved in a different study, you cannot join this one.
  • Patients who have a history of drug or alcohol abuse. If you have had problems with substance abuse, you may not be eligible for the study.
  • Patients who have had a recent change in their epilepsy medication. If your medication has been adjusted recently, you might not be able to participate.
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Investigated drugs

BHV-7000 is a medication being studied as an additional treatment for people with a type of epilepsy called idiopathic generalized epilepsy, which includes generalized tonic-clonic seizures. The trial aims to see how effective and safe BHV-7000 is when used alongside other treatments. The study will measure how long it takes for a person to have a second day with a seizure while taking this medication.

What is already known about the treatment

BHV-7000 – This medication is administered orally and is currently being studied in clinical trials as an adjunctive therapy for individuals with idiopathic generalized epilepsy, specifically targeting generalized tonic-clonic seizures. It is in the Phase 2/3 stage of clinical trials, where its efficacy, safety, and tolerability are being evaluated. The main therapeutic indication for BHV-7000 is to reduce the frequency of generalized tonic-clonic seizures. At the molecular level, it works by modulating specific neurotransmitter pathways in the brain to stabilize neuronal activity. BHV-7000 is classified pharmacologically as an antiepileptic drug.

Investigated diseases

Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures – This is a type of epilepsy characterized by seizures that involve the entire brain from the onset. The seizures, known as generalized tonic-clonic seizures, typically begin with a loss of consciousness and muscle stiffening, followed by rhythmic muscle contractions. These seizures can occur without any identifiable cause, hence the term "idiopathic." The condition often starts in childhood or adolescence and can continue into adulthood. The frequency and severity of the seizures can vary widely among individuals. Over time, the pattern of seizures may change, but the condition generally persists throughout life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-508812-45-00Protocol codeBHV7000-304Estimated enrolment246 patientsSponsorBiohaven Therapeutics Ltd.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).