A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
- Conditions
- Refractory Focal Onset Epilepsy
- Registration Number
- 2023-508811-21-00
- Lead Sponsor
- Biohaven Therapeutics Ltd.
- Brief Summary
To compare the efficacy of each of 2 dose strengths of BHV-7000 to placebo as adjunctive therapy for refractory focal onset epilepsy as measured by the proportion of subjects that have at least a 50% reduction in seizures per month (28 days).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Not specified
- Target Recruitment
- 214
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. 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
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 (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.)
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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the DBP compared to the OP. Proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the DBP compared to the OP.
- Secondary Outcome Measures
Name Time Method Change in log-transformed 28-day adjusted seizure frequency from OP over the 8-week DBP. Change in log-transformed 28-day adjusted seizure frequency from OP over the 8-week DBP.
Change in log-transformed 28-day adjusted seizure frequency from OP over the first month of the DBP. Change in log-transformed 28-day adjusted seizure frequency from OP over the first month of the DBP.
Proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the DBP compared to the OP. Proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the DBP compared to the OP.
Proportion of subjects that are seizure free during the DBP. Proportion of subjects that are seizure free during the DBP.
Change in log-transformed 7-day adjusted seizure frequency from OP over the first week of the DBP. Change in log-transformed 7-day adjusted seizure frequency from OP over the first week of the DBP.
Proportion of subjects at Week 8 with PGI-C response of “minimally improved”, “much improved” or “very much improved”. Proportion of subjects at Week 8 with PGI-C response of “minimally improved”, “much improved” or “very much improved”.
Safety is assessed by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, moderate and severe AEs and grade 3 and 4 laboratory abnormalities. Safety is assessed by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, moderate and severe AEs and grade 3 and 4 laboratory abnormalities.
Trial Locations
- Locations (115)
Accel Research
🇺🇸Birmingham, Alabama, United States
Xenoscience, Inc.
🇺🇸Phoenix, Arizona, United States
ARENSIA Exploratory Medicine
🇺🇸Phoenix, Arizona, United States
Amicis Research Center
🇺🇸Lancaster, California, United States
Memorialcare Miller Children's & Women's Hospital Long Beach
🇺🇸Long Beach, California, United States
Profound Research LLC
🇺🇸Poway, California, United States
Kaiser Permanente
🇺🇸Aurora, Colorado, United States
UConn Health
🇺🇸Farmington, Connecticut, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Dm Healthworks
🇺🇸Kissimmee, Florida, United States
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