The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy.
Participants who previously participated in EP0132 (NCT05109234) and/or N01269 (NCT04666610) and qualify for entry into EP0224 as per the EP0132 or N01269 protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)
Participants for whom a reasonable benefit from long-term administration of Brivaracetam (BRV) is expected in the opinion of the Investigator
Male and female A male participant must agree to use contraception during the treatment period and for at least 2 days after the final dose of investigational medicinal product (IMP) and refrain from donating sperm during this period.
Participant has a history or presence of paroxysmal nonepileptic seizures
Participant has severe medical, neurological, or psychiatric disorders or laboratory values which could, at the discretion of the Investigator, affect safe participation in the study or would preclude appropriate study participation
Participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment
Participant has active suicidal ideation prior to study entry as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) (for participants 6 years of age or older) or clinical judgment (for participants younger than 6 years of age). The participant should be referred immediately to a Mental Healthcare Professional
Single group
Brivaracetam Film-coated tablet
DrugDrug: Brivaracetam Film-coated tablet Pharmaceutical form: Film-coated tablet Route of administration: Oral use Brivaracetam film-coated tablet \[10, 25 or 50 mg\] will be administered twice per day in equal doses.
Brivaracetam oral solution
DrugPharmaceutical form: Oral solution Route of administration: Oral use Brivaracetam oral solution \[10 mg/mL\]) will be administered twice per day in equal doses.
Incidence of treatment-emergent adverse events (TEAEs) during the study
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).
Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of investigational medicinal product (IMP) during the study
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).
Incidence of serious adverse events (SAEs) during the study
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Results in permanent or significant disability/incapacity * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Incidence of IMP related TEAEs during the study
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).
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