Brivaracetam safety and tolerability in children and teens with seizures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ep0156 815
  Kodaira-shi, Japan Recruiting
• Ep0156 817
  Osaka, Japan Recruiting
• Ep0156 818
  Ōbu, Japan Recruiting
• Ep0156 819
  Ōmura, Japan Recruiting
• Ep0156 816
  Sendai, Japan Recruiting
• Ep0156 814
  Shizuoka, Japan Recruiting

Study contacts

• Study coordinator: UCB Cares
• Email: UCBCares@ucb.com
• Phone: 0018445992273

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.