SP0968
SP0968
A Multicenter, Open-Label, Randomized, Active Comparator Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
Brief summary
The purpose of the study is to evaluate the efficacy of lacosamide (LCM) versus an Active Comparator chosen based on standard of care (StOC) in severe and nonsevere seizure burden (defined as total minutes of electroencephalographic neonatal seizures (ENS) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (AED) treatment.
Medical Condition
Electroencephalographic neonatal seizures
Min. Age
-
Max. Age
28
Days
Who Can Join?
All
Status
Recruiting
Inclusion criteria
-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)
Exclusion criteria
-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
Study Medication Description
Study Medication:
Vimpat®
Other Descriptive Name:
lacosamide
Placebo
No
Comparator:
Yes
Refer to a friend
Study Dates
March 2021
Actual Start Date of Enrollment
August 2024
Planned Study Completion Date
General Information
Study ID:
SP0968
EudraCT Number:
2020-001066-10
CT.gov Number:
NCT04519645
Phase:
Phase 2