a study to evaluate the efficacy, safety, and tolerability of brivaracetam as monotherapy in patients 2 to 25 years of age with childhood absence epilepsy or juvenile absence epilepsy

Conditions: Childhood Absence Epilepsy; Juvenile Absence Epilepsy

Summary: the purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (cae) or juvenile absence epilepsy (jae).


Eligibility criteria:
inclusion criteria: * study participant is 2 to 25 years of age inclusive, at the time of signing the informed consent. no study participants from 2 to \<4 years of age will be included in stage 1 * study participant is diagnosed with either childhood absence epilepsy (cae) or juvenile absence epilepsy (jae) as defined by the international league against epilepsy (ilae) criteria * study participants 2 to \<4 years of age and participants who had onset of absence seizures at an age younger than 4 years must have a negative glucose transporter type 1 deficiency syndrome (glut1ds) genetic test * study participant is untreated with antiepileptic drugs (aeds) or pretreated for absence seizures with a maximum of 2 historical aeds, but without aed treatment for a period of at least 5 half-lives of the aed before randomization into this study. the ucb study physician should be consulted if in doubt * study participant has electroencephalogram (eeg) evidence of bilateral synchronous, symmetric generalized paroxysmal spike waves (2.5-6 hertz) with normal background activity and with at least 1 electrographically recorded seizure lasting 3 seconds or more on a 1-hour eeg with hyperventilation (hv) while awake at visit 1 (v1), or on a historical eeg up to 12 weeks before enrollment * study participant has a history of clinically evident absence seizures occurring on at least 3 days per week in the 2 weeks prior to enrollment * study participant is without treatment with psychoactive drugs or on a stable dose for at least 2 weeks prior to randomization * study participant has normal neurological examination, head size, development and cognition * body weight is ≥9 kg * male and female a) a sexually active male study participant must agree to use contraception during the treatment period and for at least 2 days, corresponding to the time needed to eliminate study treatment, after the last dose of study treatment and refrain from donating sperm during this period b) a female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: the study participant is premenarchial or a woman of childbearing potential (wocbp) who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the last dose of study treatment, corresponding to the time needed to eliminate study treatment * study participant provides consent/assent, and the study participant's parent/legal representative/caregiver provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol exclusion criteria: * study participant has a history of nonfebrile seizures other than absence seizures (eg, generalized tonic-clonic seizures or myoclonic seizures) * study participant has a history of absence status epilepticus * study participant has a history or presence of paroxysmal nonepileptic seizures * study participant has a clinically relevant electrocardiogram (ecg) abnormality in the opinion of the principal investigator * study participant has hepatic impairment (child pugh score a, b, or c) based on the investigator's assessment * study participant has a history of major psychiatric disease or any clinically significant medical condition that would preclude appropriate study participation * study 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 study participants 6 years or older) or clinical judgement (for study participants younger than 6 years). the study participant should be referred immediately to a mental healthcare professional * study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt). the study participant should be immediately evaluated by a mental healthcare professional to address safety concerns * study participant with known fructose intolerance or hypersensitivity of any of the ingredients in brivaracetam oral solution * study participant has end-stage kidney disease requiring dialysis * concomitant use of rifampicin/rifampin; prior use must have been stopped at least 2 months before randomization * concomitant use of strong cyp2c19 inhibitors like fluconazole, fluoxetine and fluvoxamine, prior use must have been stopped at least 1 week before randomization * study participant has participated in another study of an investigational medicinal product (imp; and/or an investigational device) within the previous 30 days prior to informed consent * study participant has clinical or eeg findings not consistent with a diagnosis of childhood absence epilepsy (cae) or juvenile absence epilepsy (jae)

Keywords: brivaracetam briviact epilepsy childhood absence epilepsy juvenile absence epilepsy cae jae