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

Location: at UCLA
Dates: study started March 2021
completion around August 2025
Principal Investigator: by Lekha M. Rao, MD (ucla)

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: March 2021
Completion Date: August 2025 (estimated)
Sponsor: UCB Biopharma SRL
ID: NCT04519645
Phase: Phase 2 research study
Study Type: Interventional
Participants: Expecting 32 study participants
Last Updated: May 2024