Overview

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

Status:
Recruiting

Trial end date:
2022-03-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

UCB Biopharma SRL

Treatments:

Lacosamide