Tests brivaracetam for long-term safety in children with epilepsy
Checks long-term safety of brivaracetam in children and teens with epilepsy.
Plain-language title generated from the registry record
Registry title: A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
Key facts
- Where
- Prague, CzechiaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with epilepsy. It checks long-term safety of brivaracetam added to their other seizure medicines.
- Age
- From 1 month of age. In Japan, new participants must be 4 years to under 16 years old.
- Sex
- All sexes can join.
- Disease stage
- Confirmed epilepsy. In Japan, new participants need focal epilepsy and seizures that stay uncontrolled after at least 1 antiepileptic drug, with at least 1 partial-onset seizure in the 4-week screening period.
- Earlier treatment
- Continuing participants took part in core study N01266 and/or N01349. In Japan, new participants must have tried at least 1 antiepileptic drug.
- Biomarker or test result
- In Japan, new participants need an EEG reading that fits focal epilepsy within the last 10 years.
Main reasons for not taking part
- Severe medical, nerve or mental health problems that could affect safety
- Taking part in another trial of an investigational medicine or device other than brivaracetam
- Continuing participants aged 6 or older with a past suicide attempt or suicidal thoughts in the past 6 months
- Japan: history of primary generalized epilepsy, psychogenic non-epileptic seizures or febrile seizures
- Japan: status epilepticus in the 30 days before screening or during screening
Read by machine on 12 November 2026.
Where in Czechia
- Ep0156 240Prague, CzechiaContact: UCB CaresNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- UCB Biopharma SRL
- Trial code
- NCT04715646
- Record updated
- 27 July 2026
- Original description
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.Read full original descriptionShow less
Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
Inclusion: Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 [NCT01364597] and/or N01349 [NCT03325439]; Study participant is ≥ 4 years to < 16 years of age; Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years; Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED); Study participant had at least 1 POS during the 4-week Screening Period.
Exclusion: Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV); Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period; Study participant had major surgery within 6 months prior to the ScrV; Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures; Study participant has any clinically significant illness; Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant; Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results; Study participant ≥ 6 years of age has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS); Study participant has a clinically significant ECG abnormality.