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

CB Biopharma SR0 个研究点目标入组 79 人开始时间: 2020年12月9日最近更新: 2024年6月24日

研究概览

暂无简介。

•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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 79
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 4
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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 (CSSRS)
•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

发起方

CB Biopharma SR