A study to evaluate the efficacy, safety, and pharmacokinetics of lacosamide in neonates with repeated electroencephalographic neonatal seizures

Phase 1

• Conditions: Electroencephalographic Neonatal Seizures (ENS); Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-001066-10-Outside-EU/EEA
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-06
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

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)
Are the trial subjects under 18? yes
Number of subjects for this age range: 32
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified