Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

Launched by BIOHAVEN THERAPEUTICS LTD. · Mar 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BHV-7000 to see if it can help adults with refractory focal epilepsy, which means their seizures are difficult to control with current medications. The trial is looking for adults aged 18 to 75 who have been diagnosed with focal epilepsy for at least a year and have not found relief from at least two different seizure medications. Participants will need to keep track of their seizures in a diary and will be currently using at least one anti-seizure medication.

If you or a loved one qualify, you can expect to receive close monitoring and care during the trial. This study is currently recruiting participants, so if you're interested, it's a good opportunity to potentially find a new treatment option. It's important to note that there are specific criteria about prior seizure history and other treatments that will be considered before enrolling in the study.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Male and Female participants 18 to 75 years of age at time of consent.
• • 2. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.
• • a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures with clinically observable signs and/or symptoms iii. Focal to bilateral tonic-clonic seizures
• • 3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
• • 4. Ability to keep accurate seizure diaries
• • 5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total
• Key Exclusion Criteria:
• • 1. History of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired consciousness for \> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.
• • 2. History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
• • 3. Resection neurosurgery for seizures \<4 months prior to the screening visit.
• • 4. Radiosurgery performed \<2 years prior to the screening visit.
• • 5. Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms.
• • 6. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator