Clinical trial NCT05109234: A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
Official title: A Multicenter, Open-Label, Single-Arm Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Childhood Absence Epilepsy
Juvenile Absence Epilepsy
Keywords: Childhood absence epilepsy
Juvenile absence epilepsy
Brivaracetam
Phase 3
Briviact
CAE
JAE
Epilepsy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2021-11-05
Enrollment: 84
Sex: ALL
Minimum age (years): 2
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the long-term safety, tolerability and efficacy of brivaracetam in pediatric study participants with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).


Eligibility criteria: Inclusion Criteria:

* Participants who previously participated in N01269 (NCT04666610) and qualify for entry into EP0132 as per N01269 (NCT04666610) 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

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 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 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 fructose intolerance or known hypersensitivity to any components of brivaracetam (BRV) or excipients or a drug with similar chemical structure. Note that the tablets contain lactose
* Study participant has end-stage kidney disease requiring dialysis
* 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

Primary outcomes:
measure: Percentage of participants with treatment-emergent adverse events (TEAEs)
timeFrame: From Entry Visit up to the Safety Visit (Month 26)
measure: Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment
timeFrame: From Entry Visit until End of Down-Titration Period (Month 26)
Secondary outcomes:
measure: Percentage of participants with serious adverse events (SAEs) during the study
timeFrame: From Entry Visit up to the Safety Visit (Month 26)
measure: Percentage of participants with study drug-related treatment-emergent adverse events (TEAEs)
timeFrame: From Entry Visit up to the Safety Visit (Month 26)
measure: Percentage of participants with absence seizure freedom within 4 days prior to or during the 1-hour electroencephalogram (EEG) at each applicable visit
timeFrame: From Full Evaluation Visit (Month 6) up to the Final Visit (Month 24)
measure: Percentage of participants with absence seizure freedom based on diary over the entire evaluation period and by 3-month time intervals
timeFrame: From Entry Visit up to the Final Visit (Month 24)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Ep0132 115
state: Alabama
city: Orange
country: United States
facility: Ep0132 105
state: California
city: Augusta
country: United States
facility: Ep0132 110
state: Georgia
city: New Brunswick
country: United States
facility: Ep0132 100
state: New Jersey
city: Winston-Salem
country: United States
facility: Ep0132 109
state: North Carolina
city: Tbilisi
country: Georgia
facility: Ep0132 400
city: Tbilisi
country: Georgia
facility: Ep0132 401
city: Tbilisi
country: Georgia
facility: Ep0132 402
city: Tbilisi
country: Georgia
facility: Ep0132 403
city: Tbilisi
country: Georgia
facility: Ep0132 405
city: Messina
country: Italy
facility: Ep0132 323
city: Milano
country: Italy
facility: Ep0132 321
city: Pavia
country: Italy
facility: Ep0132 320
city: Roma
country: Italy
facility: Ep0132 322
city: Roma
country: Italy
facility: Ep0132 325
city: Verona
country: Italy
facility: Ep0132 326
city: Bucuresti
country: Romania
facility: Ep0132 562
city: Iasi
country: Romania
facility: Ep0132 560
city: Timişoara, Judeţ Timiş
country: Romania
facility: Ep0132 561
city: Bardejov
country: Slovakia
facility: Ep0132 632
city: Dubnica Nad Vahom
country: Slovakia
facility: Ep0132 630
city: Dnipro
country: Ukraine
facility: Ep0132 600
city: Dnipro
country: Ukraine
facility: Ep0132 601
city: Uzhgorod
country: Ukraine
facility: Ep0132 607
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: