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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT04519645•UCB Biopharma SRL

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

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

Locations (18)

Sp0968 101

La Jolla, California, United States

Sp0968 108

Long Beach, California, United States

Sp0968 116

Los Angeles, California, United States

Sp0968 190

San Diego, California, United States

Sp0968 118

Aurora, Colorado, United States

Sp0968 104

Jacksonville, Florida, United States

Sp0968 107

Miami, Florida, United States

Sp0968 112

Iowa City, Iowa, United States

Sp0968 125

Valhalla, New York, United States

Sp0968 117

Portland, Oregon, United States

Key Dates

Start Date

March 31, 2021

Primary Completion Date

August 6, 2024

Completion Date

October 31, 2024

Last Updated

October 3, 2025

Enrollment

ACTUAL participants

Conditions

Electroencephalographic Neonatal SeizuresEpilepsy

Interventions

Lacosamide intravenous

DRUG

Lacosamide oral

DRUG

Active Comparator

OTHER

Thalamus Seizure Detection With a Deep Brain Stimulator System

NCT06700356

Epilepsy; Seizure

View study

RECRUITINGPHASE1

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

NCT02531880

Epilepsy

View study

RECRUITINGNA

Intracranial Investigation of Neural Circuity Underlying Human Mood

NCT05871372

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

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