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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Study participant is without treatment with psychoactive drugs or on a stable dose for at least 2 weeks prior to randomization |
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Study participant has normal neurological examination, head size, development and cognition |
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Body weight is ≥9 kg |
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Male and female |
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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 |
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Study participant is capable of and provides consent/assent, and the study |
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participant's parent/legal representative/caregiver provides signed informed |
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consent for minor study participants, which includes compliance with the |
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requirements and restrictions listed in the informed consent form (ICF) and in |
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this protocol |
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Study participant has a history of nonfebrile seizures other than absence seizures (eg, generalized tonic-clonic seizures or myoclonic seizures)
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Study participant has a history of absence status epilepticus
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Study participant has a history or presence of paroxysmal nonepileptic seizures
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Study participant has a clinically relevant electrocardiogram (ECG) abnormality in the opinion of the Principal Investigator
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Study participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment
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Study participant has a history of major psychiatric disease or any clinically significant medical condition that would preclude appropriate study participation
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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
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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
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Study participant with known fructose intolerance or hypersensitivity of any of the ingredients in brivaracetam oral solution
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Study participant has end-stage kidney disease requiring dialysis
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Concomitant use of rifampicin/rifampin; prior use must have been stopped at least 2 months before randomization
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Concomitant use of strong CYP2C19 inhibitors like fluconazole, fluoxetine and fluvoxamine, prior use must have been stopped at least 1 week before randomization
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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
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Study participant has clinical or EEG findings not consistent with a diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)
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