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
- Leuven, BelgiumSee the site
- Phase
- Phase 3
Where in Belgium
- Ep0156 204Leuven, BelgiumNo 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?
Trial 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.