A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures (LENS)

  • STATUS
    Recruiting
  • End date
    Sep 22, 2022
  • participants needed
    32
  • sponsor
    UCB Biopharma SRL
Updated on 22 March 2022
midazolam
seizure
levetiracetam
electroencephalogram
antiepileptics
lacosamide
anti-epileptic drug

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.

Details
Condition Electroencephalographic Neonatal Seizures, Epilepsy
Treatment Active comparator, Lacosamide intravenous, Lacosamide oral
Clinical Study IdentifierNCT04519645
SponsorUCB Biopharma SRL
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

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
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