A Multicenter, Open-Label, Randomized, Active Comparator Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures - LENS

CB Biopharma SR0 个研究点开始时间: 2021年9月6日最近更新: 2021年9月13日

适应症

试验速览

暂无简介。

•-Participant must be at least 34 weeks of gestational age (GA)
•-Participants who have confirmation on video-electroencephalogram (EEG) of =2 minutes of cumulative electroencephalographic neonatal seizures (ENS) or =3 identifiable ENS prior to entering the Treatment Period
•-Participants must have received either phenobarbital (PB), levetiracetam (LEV), or midazolam (MDZ) (in any combination) before entering the study
•-Participant weighs at least 2.3 kg at the time of enrollment Informed consent
•-An Independent Ethics Committee (IEC)-approved written informed consent form (ICF) is signed and dated by the participant’s parent(s) or legal representative(s)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 32
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•-Participant with seizures responding to correction of metabolic disturbances (hypoglycemia, hypomagnesemia, or hypocalcemia) or with seizures for which a targeted, known treatment is available
•-Participant has seizures related to prenatal maternal drug use or drug withdrawal
•-Participant has a clinically relevant electrocardiogram (ECG) abnormality, in the opinion of the investigator
•-Participant receiving treatment with phenytoin (PHT), lidocaine (LDC), or other sodium channel blockers at any time

发起方

CB Biopharma SR