NCT04715646RecruitingPhase 3
A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
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
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 14 Jan 2021
- Start date
- 11 Mar 2021
- Primary completion date
- 8 Jul 2030
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Epilepsy
- NCT number
- NCT04715646
- EudraCT number
- 2020-003664-29
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 70
- From 11 Mar 2021 to the primary completion date, 8 Jul 2030
- 36 sites in 11 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 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
Other illness
- Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
- Study participant has any clinically significant illness
Lab values
- 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
Age
- \- 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)
Other
- Study participant has a clinically significant ECG abnormality
Who the study is looking for
- 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
Age in the registry: 1 month to - · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.