MedTrace Logo

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

NCT04519645 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-10-03

Study results available
· View outcomes & findings →

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.

Conditions

  • Electroencephalographic Neonatal Seizures
  • Epilepsy

Interventions

DRUG

Lacosamide intravenous

Study participants will receive lacosamide (LCM) as an intravenous (iv) infusion during the Treatment Period.

DRUG

Lacosamide oral

Study participants may receive lacosamide (LCM) as an oral solution during the Extension Period.

OTHER

Active Comparator

Active Comparator treatment will be chosen and dosed based on StOC (per local practice and treatment guidelines).

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2024-08-06
Completion
2024-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04519645 on ClinicalTrials.gov