Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.

Phase 2/3 Completed 103 enrolled UCB BIOSCIENCES, Inc.

NaSingle-groupOpen-labelTreatment

Summary

EP0060 is a multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) Lacosamide (LCM) in pediatric subjects \>= 1 month to \< 17 years of age with epilepsy.

Timeline

Start: 2017-05-30
Primary completion: 2019-06-28
Completion: 2019-06-28

Publications

Results Farkas MK, Beller C, Bozorg A, McClung C, Roebling R, Yates T, Yuen N, Makedonska I. Safety and tolerability of short-term infusions of intravenous lacosamide in pediatric patients with epilepsy: An open-label, phase 2/3 trial. Epilepsia Open. 2023 Mar;8(1):146-153. doi: 10.1002/epi4.12682. Epub 2023 Jan 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lacosamide	Other / unclassified	2 mg/kg	Intravenous
Subject	Lacosamide	Other / unclassified	12 mg/kg	Intravenous
Subject	Lacosamide	Other / unclassified	100 mg	Intravenous
Subject	Lacosamide	Other / unclassified	600 mg	Intravenous

Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.

Summary

Timeline

Publications

Drugs

Indications