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
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundacio Assistencial De Mutua De Terrassa Fpc Coordinator of this site? Confirm its status | Terrassa | Spain | Completed |
| Azienda Ospedaliera Universitaria Gaetano Martino Messina Coordinator of this site? Confirm its status | Messina | Italy | Completed |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Neurological Institute Foundation Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Bambino Gesu Childrens Hospital Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Completed |
| Centrul National Clinic De Recuperare Neuropsihomotorie Copii Doctor Nicolae Robanescu Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Spitalul Clinic De Urgenta Pentru Copii Sfanta Maria Iasi Coordinator of this site? Confirm its status | Jassi | Romania | Completed |
| Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara Coordinator of this site? Confirm its status | Timișoara | Romania | Completed |
| IN MEDIC, s.r.o. Coordinator of this site? Confirm its status | Bardejov | Slovakia | Completed |
| Konzilium s.r.o. Coordinator of this site? Confirm its status | Nova Dubnica | Slovakia | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.