Purpose

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.

Conditions

Eligibility

Eligible Ages
Under 28 Days
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lacosamide
Study participants randomized to this arm will receive lacosamide (LCM) as an intravenous infusion in the Treatment Period and may continue to receive lacosamide in the Extension Period. Participants should be switched to oral dosing of LCM as soon as medically possible during the Extension Period.
  • Drug: Lacosamide intravenous
    Study participants will receive lacosamide (LCM) as an intravenous (iv) infusion during the Treatment Period.
    Other names:
    • LCM
  • Drug: Lacosamide oral
    Study participants may receive lacosamide (LCM) as an oral solution during the Extension Period.
    Other names:
    • LCM
Active Comparator
Active Comparator
Study participants randomized to this arm will receive Active Comparator chosen based on standard of care (StOC) in the Clinical Practice in the Treatment Period and may continue to receive in the Extension Period.
  • Other: Active Comparator
    Active Comparator treatment will be chosen and dosed based on StOC (per local practice and treatment guidelines).

Recruiting Locations

Sp0968 113
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
UCB Biopharma SRL

Study Contact

UCB Cares
001 844 599 2273
UCBCares@ucb.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.