Childhood absence epilepsy (CAE) Juvenile absence epilepsy (JAE)
Conditions
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants who previously participated in N01269 and qualify for entry into EP0132 as per N01269 protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE), and for whom a reasonable benefit from long-term administration of brivaracetam (BRV) is expected, in the opinion of the Investigator - 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 - A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: 1. The study participant is premenarchal OR 2. 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 medication, corresponding to the time needed to eliminate study treatment - Study participant is capable of and 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 Are the trial subjects under 18? yes Number of subjects for this age range: 112 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Study participant has a history or presence of paroxysmal nonepileptic seizures - Study 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 - 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 judgment (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 Investigator must immediately refer the study participant to a Mental Healthcare Professional - Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study - Participant has a known hypersensitivity to any components of brivaracetam (BRV) or excipients or a drug with similar chemical structure. Note that the tablets contain lactose - Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin - Study participant has planned participation in any clinical study on an investigational drug or device - Study participant has poor compliance with the visit schedule or medication intake in the core study in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the long-term safety and tolerability of brivaracetam in pediatric study participants with childhood absence epilepsy or juvenile absence epilepsy.;Secondary Objective: Investigate long-term efficacy of BRV pediatric study participants with childhood absence epilepsy or juvenile absence epilepsy.;Primary end point(s): 1. Percentage of participants with treatment-emergent adverse events (TEAEs) 2. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment;Timepoint(s) of evaluation of this end point: 1: From Entry Visit up to the Safety Visit (Month 26) 2: From Entry Visit until End of Down-Titration Period (Month 26) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of participants with serious adverse events (SAEs) during the study 2. Percentage of participants with study drug-related treatment-emergent adverse events (TEAEs) 3. Percentage of participants with absence seizure freedom within 4 days prior to or during the 1-hour electroencephalogram (EEG) at each applicable visit 4. Percentage of participants meeting the criteria for absence seizure freedom based on diary over the entire evaluation period and 3-month time intervals;Timepoint(s) of evaluation of this end point: 1 + 2: From Entry Visit up to the Safety Visit (Month 26) 3: From Full Evaluation Visit (Month 6) up to the Final Visit (Month 24) 4: From Entry Visit up to the Final Visit (Month 24) | — |
Countries
Australia, Belgium, Georgia, Hungary, Italy, Poland, Romania, Spain, Ukraine, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed