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

UCB

Status and phase

Completed

Phase 3

Conditions

Epilepsy

Treatments

Drug: Lacosamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT04627285

2022-502639-21-00 (Registry Identifier)

EP0151

2020-001478-30 (EudraCT Number)

U1111-1286-3095 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

48 patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

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