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

• Status: Enrolling by invitation
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma SRL
• Treatments: Lacosamide

Criteria

Inclusion Criteria:

• Participant is male or female, aged <6 years at the time of signing the Informed Consent Form (ICF)

• Participant has completed participation in NCT01964560 (EP0034) or NCT00938912 (SP848)

• Participant is expected to benefit from participation, in the opinion of the Investigator

Exclusion Criteria:

• Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study

• Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol

• Participant is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)

• Participant meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for NCT01964560 (EP0034) or NCT00938912 (SP848), or is experiencing an ongoing serious adverse event (SAE)

• Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study