drugset / Trial / NCT04627285

A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment

NCT04627285

Phase 3 Completed 48 enrolled UCB Biopharma SRL
NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to assess the long-term use of lacosamide oral solution dosed at 2 mg/kg/day to 12 mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or NCT00938912 (SP848).

Timeline

Start
2020-12-28
Primary completion
2025-02-12
Completion
2025-02-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Lacosamide Other / unclassified 2 mg/kg Oral
Subject Lacosamide Other / unclassified 12 mg/kg Oral

Indications