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NCT05109234CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 22 Oct 2025

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
84 (actual)
First submitted
25 Oct 2021
Start date
30 Mar 2022
Primary completion date
18 Mar 2025
Lead sponsor
UCB Biopharma SRL
Diseases
Epilepsy
NCT number
NCT05109234
EudraCT number
2020-002769-33

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 84
  • From 30 Mar 2022 to the primary completion date, 18 Mar 2025
  • 24 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • Study participant has a history or presence of paroxysmal nonepileptic seizures
  • Study participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment
  • 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

Lab values

  • 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

Other

  • Study participant has a clinically relevant electrocardiogram (ECG) abnormality in the opinion of the Principal Investigator

Who the study is looking for

  • 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:
    • The study participant is premenarchal 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 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

Age in the registry: 2 years to 26 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ep0132 405
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
Ep0132 401
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
Ep0132 400
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
Ep0132 402
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
Ep0132 403
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
Ep0132 323
Coordinator of this site? Confirm its status
MessinaItalyUnknown status
Ep0132 321
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Ep0132 320
Coordinator of this site? Confirm its status
PaviaItalyUnknown status
Ep0132 322
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Ep0132 325
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Ep0132 326
Coordinator of this site? Confirm its status
VeronaItalyUnknown status
Ep0132 562
Coordinator of this site? Confirm its status
BucharestRomaniaUnknown status
Ep0132 560
Coordinator of this site? Confirm its status
IașiRomaniaUnknown status
Ep0132 561
Coordinator of this site? Confirm its status
Timişoara, Judeţ TimişRomaniaUnknown status
Ep0132 632
Coordinator of this site? Confirm its status
BardejovSlovakiaUnknown status
Ep0132 630
Coordinator of this site? Confirm its status
Dubnica nad VáhomSlovakiaUnknown status
Ep0132 601
Coordinator of this site? Confirm its status
DniproUkraineUnknown status
Ep0132 600
Coordinator of this site? Confirm its status
DniproUkraineUnknown status
Ep0132 607
Coordinator of this site? Confirm its status
UzhhorodUkraineUnknown status
Ep0132 110
Coordinator of this site? Confirm its status
AugustaUnited StatesUnknown status
Ep0132 115
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Ep0132 100
Coordinator of this site? Confirm its status
New BrunswickUnited StatesUnknown status
Ep0132 105
Coordinator of this site? Confirm its status
OrangeUnited StatesUnknown status
Ep0132 109
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.