EP0151
EP0151
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
Brief 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).
Medical Condition
Epilepsy
Min. Age
2
Years
Max. Age
5
Years
Who Can Join?
All
Status
Active, not recruiting
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
Study Medication Description
Study Medication:
Vimpat®
Other Descriptive Name:
lacosamide
Placebo
No
Comparator:
No
Refer to a friend
Study Dates
December 2020
Actual Start Date of Enrollment
July 2025
Planned Study Completion Date
General Information
Study ID:
EP0151
EudraCT Number:
2020-001478-30
CT.gov Number:
NCT04627285
Phase:
Phase 3