Clareo Health | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Biopharma SRL
Age
0–0
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant must be ≥34 weeks of corrected gestational age (CGA), \<46 weeks of CGA, and \<28 days of postnatal age (PNA)
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)
You may not be if
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
