A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures

Launched by BIOHAVEN THERAPEUTICS LTD. · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BHV-7000 to see if it is effective and safe for adults with idiopathic generalized epilepsy, specifically those who experience generalized tonic-clonic seizures (a type of seizure that causes stiffening of the body and shaking). The trial is currently recruiting participants aged 18 to 75 who have been diagnosed with this type of epilepsy for at least six months. To be eligible, participants must have tried at least two different epilepsy medications without achieving good control of their seizures and should currently be using at least one anti-seizure medication.

Participants in the trial will be asked to keep a record of their seizures and may receive BHV-7000 alongside their current treatment. The study will also have a follow-up phase where participants can continue to receive the treatment. This trial is an important step in finding new options for people whose seizures are hard to manage with existing medications. If you or a loved one fits the eligibility criteria and are interested in learning more, consider discussing it with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and Female participants 18 to 75 years of age at time of consent.
• • Diagnosis of Idiopathic Generalized Epilepsy at least 6 months prior to the screening visit, defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.
• • 1. Subject has probable GTC seizures in the setting of IGE, meaning GTC seizures and either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-wave on EEG and no focal abnormality (asymmetric spike-wave fragment is allowed) AND/OR a clear history of absence seizures or myoclonic jerks
• • 2. Subjects with possible GTC seizures in the setting of IGE, meaning GTC and either Normal EEG OR Generalized epileptiform EEG abnormality with atypical spike-wave and no focal abnormality (asymmetric spike-wave fragment is allowed).
• • Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
• • Ability of subject or caregiver to keep accurate seizure diaries
• • Current treatment with at least 1 to 3 ASMs as part of no more than 4 epilepsy treatments in total (e.g., each ASM is considered 1 treatment. Other epilepsy therapies including devices and diet therapy are allowed; together these other therapies count as 1 treatment).
• • Accurate history of having at least 3 days with a GTC seizure evenly spread throughout the 16 weeks prior to the screening visit, such that a subject had at least 1 day with a GTC seizure during the first 8 weeks and at least 1 day with a GTC seizure during the second 8 weeks.
• Exclusion Criteria:
• • History of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired conscious for \> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.
• • History of repetitive/cluster GTC seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having repetitive/cluster GTC seizures count during the screening phase.
• • Any condition that would interfere with and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator