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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

1
Months

Max. Age

-

Who Can Join?

All

Status

Active, not recruiting
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

Study Medication Description

Study Medication:

Briviact®

Other Descriptive Name:

brivaracetam

Placebo

No

Comparator:

No

Study Dates

March 2021

Actual Start Date of Enrollment

July 2029

Planned Study Completion Date

General Information

Study ID:
EP0156
EudraCT Number:
2020-003664-29
CT.gov Number:
NCT04715646
Phase:
Phase 3

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