Resumen

El propósito de este estudio es determinar si BHV-7000 es eficaz en el tratamiento de la epilepsia focal refractaria.

Descripción detallada

Este estudio tiene dos partes, Parte A y Parte B. La Parte A es aleatorizada 1:1:1 con BHV-7000 25 mg, BHV-7000 50 mg o placebo correspondiente. La Parte B es aleatorizada 1:1 con BHV-7000 75 mg o placebo correspondiente. La Parte B comenzará después de la Parte A.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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 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

Criterios de exclusión

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

Intervenciones

drug

BHV-7000

BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily

drug

BHV-7000

BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily

drug

Placebo

Matching placebo taken once daily

drug

BHV-7000

BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily

drug

Placebo

Matching placebo taken once daily

Ubicaciones

STAT Research S.A.

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

RECRUITING

Hospital General de Agudos Dr. José María Ramos Mejia

Balvanera, Ciudad Autónoma de BuenosAires, Argentina

RECRUITING

Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

RECRUITING

Hospital Británico de Buenos Aires

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

RECRUITING

Investigaciones Sanatorio Del Sur

San Miguel de Tucumán, Tucumán Province, Argentina

RECRUITING

Sanatorio de la Trinidad - Mitre

Buenos Aires, Argentina

RECRUITING

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

RECRUITING

Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI

Buenos Aires, Argentina

RECRUITING

Instituto Privado Kremer

Córdoba, Argentina

RECRUITING

Conci Carpinella - Santa Rosa N° 748

Córdoba, Argentina

RECRUITING

Estudio de fase 2/3, multicéntrico, aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia, seguridad y tolerabilidad de BHV-7000 en sujetos con epilepsia focal de inicio refractaria

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

BHV-7000

BHV-7000

Placebo

BHV-7000

Placebo

Ubicaciones

STAT Research S.A.

Hospital General de Agudos Dr. José María Ramos Mejia

Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102

Hospital Británico de Buenos Aires

Investigaciones Sanatorio Del Sur

Sanatorio de la Trinidad - Mitre

Hospital Italiano de Buenos Aires

Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI

Instituto Privado Kremer

Conci Carpinella - Santa Rosa N° 748

Patrocinadores

Contactos

Chief Medical Officer