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SP0968

A Multicenter, Open-Label, Randomized, Active Comparator Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures

Brief summary

The purpose of the study is to evaluate the efficacy of lacosamide (LCM) versus an Active Comparator chosen based on standard of care (StOC) in severe and nonsevere seizure burden (defined as total minutes of electroencephalographic neonatal seizures (ENS) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (AED) treatment.

Medical Condition

Epilepsy

Min. Age

-

Max. Age

28
Days

Who Can Join?

All

Status

Recruiting
Inclusion criteria

-Participant must be at least 34 weeks of gestational age (GA) -Participants who have confirmation on video-electroencephalogram (EEG) of ≥2 minutes of cumulative electroencephalographic neonatal seizures (ENS) or ≥3 identifiable ENS prior to entering the Treatment Period -Participants must have received either phenobarbital (PB), levetiracetam (LEV), or midazolam (MDZ) (in any combination) before entering the study -Participant weighs at least 2.3 kg at the time of enrollment Informed consent -An Independent Ethics Committee (IEC)-approved written informed consent form (ICF) is signed and dated by the participant’s parent(s) or legal representative(s)

Exclusion criteria

-Participant with seizures responding to correction of metabolic disturbances (hypoglycemia, hypomagnesemia, or hypocalcemia) or with seizures for which a targeted, known treatment is available -Participant has seizures related to prenatal maternal drug use or drug withdrawal -Participant has a clinically relevant electrocardiogram (ECG) abnormality, in the opinion of the investigator -Participant receiving treatment with phenytoin (PHT), lidocaine (LDC), or other sodium channel blockers at any time

Study Medication Description

Study Medication:

Vimpat®

Other Descriptive Name:

lacosamide

Placebo

No

Comparator:

Yes

Study Dates

March 2021

Actual Start Date of Enrollment

March 2022

Planned Study Completion Date

General Information

Study ID:
SP0968
EudraCT Number:
2020-001066-10
CT.gov Number:
NCT04519645
Phase:
Phase 2/Phase 3

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