Last updated 44 hours ago
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
390 patients around the world
Available in United States, Mexico
Biohaven Therapeutics Ltd.
7Research sites
390Patients around the world
This study is for people with
Epilepsies
Focal Epilepsy
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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.Focal seizures.Focal aware seizures with clinically observable signs and/or symptoms.Focal impaired awareness seizures with clinically observable signs and/or symptoms.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.
- 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.
Sites
Clinstile S.A de C.V.
FAICIC Clinical Research
Unidad de Investigación en Salud de Chihuahua S.C
Neurociencias Estudios Clínicos S.C. - Culiacán
Clinical Research Institute S.C.
Axis Heilsa S. de R.L. de C.V.
Accelerium Clinical Research
StudyRISE 3
SponsorBiohaven Therapeutics Ltd.
Study typeInterventional
Conditions
Focal Epilepsy
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06309966
