Fact CheckerSign in

NCT06315322CompletedPhase 3

A study to learn about the safety of long-term treatment with brivaracetam in children and young adults with childhood or juvenile absence epilepsy

A multicenter, open-label, single-arm study to evaluate long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy

Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Mar 2026

Brief summary (registry, in English)

To investigate the long-term safety and tolerability of brivaracetam (BRV) 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
31 (actual)
First submitted
2 Apr 2024
Start date
27 Nov 2024
Lead sponsor
UCB Biopharma
Diseases
Epilepsy
NCT number
NCT06315322
EU CT number
2023-508095-11-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 31
  • 14 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Lab values

  • Participant has a history or presence of paroxysmal nonepileptic seizures - 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 - Participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator’s assessment - 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 participants 6 years of age or older) or clinical judgment (for participants younger than 6 years of age). The participant should be referred immediately 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 participant’s ability to participate in this study - Participant has known fructose intolerance or a known hypersensitivity to any components of BRV or excipients or a drug with similar chemical structure - Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin - Participant is receiving any investigational drugs or using any experimental devices in addition to BRV - Participant meets a mandatory withdrawal criterion for N01269 or EP0132 or is experiencing an ongoing Serious adverse event (SAE) - Participant has poor compliance with the visit schedule or IMP intake in the preceding study in the opinion of the Investigator

Who the study is looking for

  • Participants who previously participated in EP0132 and/or N01269 and qualify for entry into EP0224 as per the EP0132 or N01269 protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE) - Participants for whom a reasonable benefit from long-term administration of Brivaracetam (BRV) is expected in the opinion of the Investigator - Male and female A male participant must agree to use contraception during the treatment period and for at least 2 days after the final dose of investigational medicinal product (IMP) and refrain from donating sperm during this period. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: ◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the final dose of IMP. - Capable of and provides informed consent/assent, and the participant’s parent/legal representative/caregiver provides signed informed consent for minor participants, which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF)/Assent form and in this protocol

Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (14)

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

SiteCityCountrySite status
Fundacio Assistencial De Mutua De Terrassa Fpc
Coordinator of this site? Confirm its status
TerrassaSpainCompleted
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Coordinator of this site? Confirm its status
MessinaItalyCompleted
IRCCS Foundation Istituto Neurologico Carlo Besta
Coordinator of this site? Confirm its status
MilanItalyCompleted
ASST Fatebenefratelli Sacco
Coordinator of this site? Confirm its status
MilanItalyCompleted
Neurological Institute Foundation Casimiro Mondino
Coordinator of this site? Confirm its status
PaviaItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyCompleted
Bambino Gesu Childrens Hospital
Coordinator of this site? Confirm its status
RomeItalyCompleted
Azienda Ospedaliera Universitaria Integrata Verona
Coordinator of this site? Confirm its status
VeronaItalyCompleted
Centrul National Clinic De Recuperare Neuropsihomotorie Copii Doctor Nicolae Robanescu
Coordinator of this site? Confirm its status
BucharestRomaniaCompleted
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
Coordinator of this site? Confirm its status
BucharestRomaniaCompleted
Spitalul Clinic De Urgenta Pentru Copii Sfanta Maria Iasi
Coordinator of this site? Confirm its status
JassiRomaniaCompleted
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
Coordinator of this site? Confirm its status
TimișoaraRomaniaCompleted
IN MEDIC, s.r.o.
Coordinator of this site? Confirm its status
BardejovSlovakiaCompleted
Konzilium s.r.o.
Coordinator of this site? Confirm its status
Nova DubnicaSlovakiaCompleted

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