NCT04519645

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2021-03-31
• Primary completion: 2024-08-06
• Completion: 2024-10-31
• First posted: 2020-08-20
• Last updated: 2025-10-03
• Results posted: 2025-10-03

Locations

18 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study