A Study of Lacosamide to Treat Neonatal Seizures

Overview

About this study

The purpose of this study is to evaluate the effectiveness of Lacosamide (LCM) vs. 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Participant must be ≥ 34 weeks of corrected gestational age (CGA), < 46 weeks of CGA, and < 28 days of postnatal age (PNA), at the time of signing the informed consent.
  • Participants who have confirmation on video-EEG of ≥ 2 minutes of cumulative ENS or ≥ 3 identifiable ENS prior to entering the Treatment Period (ENS is defined as a seizure lasting for at least 10 seconds on video-EEG), despite receiving previous AED treatment for the treatment of electroencephalographic seizures. The occurrence of ENS during an up to 1-hour period must be confirmed by the local video-EEG reader prior to randomized study drug administration. Video-EEG recording can be shortened per clinical need (e.g., if status epilepticus is detected). If possible, an attempt should be made to record at least 30 minutes of Baseline video-EEG.
  • Participants must have received either PB, LEV, or MDZ (in any combination) before entering the study.
  • Participants with or without concomitant hypothermia treatment.
  • Participant weighs at least 2.3kg at the time of enrollment.
  • An Independent Ethics Committee (IEC)-approved written 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 known severe disturbance of hemostasis, as assessed by the investigator.
  • Participant has a poor prognosis for survival, as judged by the investigator.
  • Participant has a medical condition that could be expected, in the opinion of the investigator, to interfere with study medication absorption, distribution, metabolism, or excretion.
  • Participant has a clinically relevant ECG abnormality, in the opinion of the investigator (eg, second or third degree heart block at rest or a corrected QT interval [QTc] ≥ 450ms).
  • Participant has a hemodynamically significant congenital heart disease.
  • Participant has any clinically relevant cardiac arrhythmia.
  • If participant is in the first 24 hours of life, urine output is < 1 mL/kg/hour.  If older than 24 hours, participant urine output is < 1 mL/kg/hour or serum creatinine is > 1.7 mg/dL.
  • Participant receiving treatment with PHT, LDC, or other sodium channel blockers at any time.
  • Participant requires extracorporeal membrane oxygenation.
  • Participant requires or is expected to require phototherapy or exchange transfusion due to elevated bilirubin.
  • Participant has 2 x upper limit of normal (ULN) of any of the following: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP), with the following exception:
    • For participants with perinatal asphyxia, elevation of AST, ALT, or ALP 2mg/dL.

Eligibility last updated 4/14/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Anthony Fine, M.D.

Open for enrollment

Contact information:

Bridget Neja C.N.A.

(507) 266-9150

Neja.Bridget@mayo.edu

More information

Publications

Publications are currently not available