RecruitingPhase 2/3

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

United States390 participantsStarted 2024-03-14

Plain-language summary

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male and Female participants 18 to 75 years of age at time of consent.
✓. 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.
✓. 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.
✓. Ability to keep accurate seizure diaries
✓. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total

✕. 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.
✕. History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
✕. Resection neurosurgery for seizures \<4 months prior to the screening visit.
✕. Radiosurgery performed \<2 years prior to the screening visit.
✕. 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.
✕. 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

Part B: Change from Baseline in 28-day average seizure frequency

Timeframe: Baseline, Week 8 to Week 20 of Part B

Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs

Timeframe: Week 8 to Week 20 of Part A

Part A: Number of Participants With Clinically Significant Laboratory Abnormalities

Timeframe: Week 8 to Week 20 of Part A

NCT IDNCT06132893

SponsorBiohaven Therapeutics Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Chief Medical Officer

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male and Female participants 18 to 75 years of age at time of consent.
✓. 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.
✓. 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.
✓. Ability to keep accurate seizure diaries
✓. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total

✕. 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.
✕. History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
✕. Resection neurosurgery for seizures \<4 months prior to the screening visit.
✕. Radiosurgery performed \<2 years prior to the screening visit.
✕. 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.
✕. 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

What they're measuring

Part B: Change from Baseline in 28-day average seizure frequency

Timeframe: Baseline, Week 8 to Week 20 of Part B

Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs

Timeframe: Week 8 to Week 20 of Part A

Part A: Number of Participants With Clinically Significant Laboratory Abnormalities

Timeframe: Week 8 to Week 20 of Part A