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

a study on Seizures Epilepsy

Summary

Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Lekha M. Rao, MD (ucla)
Headshot of Lekha M. Rao
Lekha M. Rao

Description

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.

Official Title

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

Keywords

Electroencephalographic Neonatal Seizures, Epilepsy, neonatal study participants, Vimpat, lacosamide, LCM, pediatric, video-EEG, Seizures, Lacosamide intravenous, Lacosamide oral, Active Comparator

Eligibility

You can join 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 CAN'T join 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

Locations

  • Sp0968 116 accepting new patients
    Los Angeles California 90095 United States
  • Sp0968 101 accepting new patients
    La Jolla California 92037 United States
  • Sp0968 121 withdrawn
    San Diego California 92123 United States
  • Sp0968 190 accepting new patients
    San Diego California 92123 United States
  • Sp0968 115 accepting new patients
    Orange California 92868 United States
  • Sp0968 108 accepting new patients
    Long Beach California 90806 United States

Lead Scientist at University of California Health

  • Lekha M. Rao, MD (ucla)
    HS Associate Clinical Professor, Pediatrics, Medicine. Authored (or co-authored) 8 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
UCB Biopharma SRL
ID
NCT04519645
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 32 study participants
Last Updated