A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures

Recruiting now · Phase 3

Conditions studied: Epilepsy

In brief

The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

Key facts

Study ID

NCT04715646

Run by

UCB Biopharma SRL

People needed

70

Starts

2021-03-11

Expected to finish

2030-07-08

Last updated by the study team

2026-07-27

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Ep0156 817 — Osaka, Japan (enrolling)
• Ep0156 814 — Shizuoka, Japan (enrolling)
• Ep0156 818 — Ōbu, Japan (enrolling)
• Ep0156 819 — Ōmura, Japan (enrolling)
• Ep0156 815 — Kodaira-shi, Japan (enrolling)
• Ep0156 816 — Sendai, Japan (enrolling)
• Ep0156 210 — Budapest, Hungary
• Ep0156 247 — Budapest, Hungary
• Ep0156 232 — Miskolc, Hungary
• Ep0156 230 — Roma, Italy
• Ep0156 803 — Bunkyō City, Japan
• Ep0156 808 — Chūō, Japan
• Ep0156 800 — Gifu, Japan
• Ep0156 807 — Hiroshima, Japan
• Ep0156 813 — Kōshi, Japan
• Ep0156 806 — Kyoto, Japan
• Ep0156 811 — Nagoya, Japan
• Ep0156 812 — Niigata, Japan
• Ep0156 805 — Sapporo, Japan
• Ep0156 809 — Shimotsuke, Japan
• Ep0156 804 — Tokyo, Japan
• Ep0156 810 — Yokohama, Japan
• Ep0156 802 — Yonago, Japan
• Ep0156 223 — Aguascalientes, Mexico
• Ep0156 609 — Culiacán, Mexico

Full record on ClinicalTrials.gov

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