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

A Multicenter, Open-Label, Follow-Up Study to Assess the Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Lacosamide	* Pharmaceutical form: Oral-solution * Route of administration: Oral use Subjects will receive lacosamide in a pre-specified sequence during the Treatment Period.

Timeline

• Start date: 2020-12-28
• Primary completion: 2025-02-12
• Completion: 2025-02-12
• First posted: 2020-11-13
• Last updated: 2025-08-28
• Results posted: 2025-08-28

Locations

15 sites across 6 countries: Georgia, Hungary, Moldova, Romania, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study