Status:
TERMINATED
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Electroencephalographic Neonatal Seizures
Epilepsy
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE2
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 mi...
Eligibility Criteria
Inclusion
- Participant must be ≥34 weeks of corrected gestational age (CGA), \<46 weeks of CGA, and \<28 days of postnatal age (PNA)
- 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
- 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
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04519645
Start Date
March 31 2021
End Date
October 31 2024
Last Update
October 3 2025
Active Locations (18)
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1
Sp0968 101
La Jolla, California, United States, 92037
2
Sp0968 108
Long Beach, California, United States, 90806
3
Sp0968 116
Los Angeles, California, United States, 90095
4
Sp0968 190
San Diego, California, United States, 92123