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Brivaracetam safety and tolerability in children and teens 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

Phase 3 Interventional UCB Pharma · NCT04715646

We will test if long-term brivaracetam is safe and well tolerated for children and adolescents with epilepsy, including those from prior pediatric brivaracetam studies and children in Japan with focal seizures.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment70 (estimated)
Ages1 Month and up
SexAll
SponsorUCB Pharma Industry-sponsored
Locations36 sites (Hawthorne, New York and 35 other locations)
Trial IDNCT04715646 on ClinicalTrials.gov

What this trial studies

EP0156 is an open-label long-term follow-up study testing the safety and tolerability of brivaracetam in pediatric participants who previously took part in neonatal study N01349 or the pediatric follow-up N01266. The study also directly enrolls Japanese children aged 4 to under 16 with uncontrolled partial-onset seizures and will collect pharmacokinetic data in those participants. Participants receive brivaracetam and are monitored over time for adverse events, laboratory changes, and overall tolerability. The trial is conducted at multiple sites including locations in the United States and Leuven, Belgium.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents with epilepsy who previously participated in brivaracetam studies N01266 or N01349, or Japanese children aged 4 to under 16 with uncontrolled partial-onset seizures who had at least one seizure during screening.

Not a fit: Children with severe medical, neurological, or psychiatric disorders, abnormal laboratory values affecting safety, or those who do not meet prior-study or Japanese enrollment criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could confirm that long-term brivaracetam is safe and tolerable in children and adolescents, supporting continued pediatric use.

How similar studies have performed: Earlier adult and pediatric brivaracetam studies, including open-label long-term follow-ups, have generally supported its tolerability, but comprehensive long-term pediatric safety data remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Inclusion criteria for long-term follow-up (LTFU) study participants only

* Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 \[NCT01364597\] and/or N01349 \[NCT03325439\]

Inclusion criteria for directly enrolled (DE) study participants in Japan only

* 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 Criteria:

Exclusion criteria for all study participants

* Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant
* Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV).

Exclusion criteria for long-term follow-up (LTFU) study participants only

\- 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)

Exclusion criteria for directly enrolled (DE) study participants in Japan only

* Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
* 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 has any clinically significant illness
* 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 has a clinically significant ECG abnormality
* Study participant had major surgery within 6 months prior to the ScrV

Where this trial is running

Hawthorne, New York and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions EpilepsyBrivaracetamPediatricChild
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.