EP0156
EP0156
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
Brief summary
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
Medical Condition
Epilepsy
Min. Age
Max. Age
Who Can Join?
Status
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 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
Study Medication Description
Study Medication:
Briviact®
Other Descriptive Name:
brivaracetam
Placebo
No
Comparator:
No
Refer to a friend
Study Dates
March 2021
Actual Start Date of Enrollment
July 2029
Planned Study Completion Date