Lacosamide oral for Neonatal Seizures

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Neonatal Seizures+1 MoreLacosamide oral - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the efficacy of lacosamide to an active comparator chosen based on standard of care in reducing seizure burden in neonates with uncontrolled seizures.

Eligible Conditions
  • Neonatal Seizures
  • Epilepsy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Across the first 48-hours of the Treatment Period (up to 48 hours)

Hour 96
Serum
Hour 48
Absolute change in seizure burden across the first 48-hours of the Treatment Period measured by continuous video-EEG compared with the Baseline video-EEG
Percent change in seizure burden across the first 48-hours of the Treatment Period measured by continuous video-EEG compared with the Baseline video-EEG
Time to response across the first 48-hours of the Treatment Period compared with the Baseline video-EEG
Time to seizure freedom across the first 48-hours of the Treatment Period compared with the Baseline video-EEG
Hour 24
Percentage of study participants who are seizure-free (100% reduction in seizure burden from Baseline) at 24 hours after start of the Treatment Period, categorized by study participants with nonsevere or severe seizure burden at Baseline
At the end of the first 48-hours of the Treatment Period
Percentage of responders at the end of the first 48-hours of the Treatment Period
Hour 2
Categorized percentage change in seizure burden in the Evaluation video-EEG compared with the Baseline video-EEG
Change in seizure burden measured in the Evaluation video-electroencephalogram (video-EEG) compared with the Baseline video-EEG
Percentage of participants with at least 80% reduction in seizure burden in the Evaluation a video-EEG compared with the Baseline video-EEG
Percentage of responders in the Evaluation video-EEG compared with the Baseline video-EEG
Day 42
Therapeutic procedure
Electrocardiogram

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Active Comparator
1 of 2
Lacosamide
1 of 2

Active Control

Experimental Treatment

32 Total Participants · 2 Treatment Groups

Primary Treatment: Lacosamide oral · No Placebo Group · Phase 2 & 3

LacosamideExperimental Group · 2 Interventions: Lacosamide oral, Lacosamide intravenous · Intervention Types: Drug, Drug
Active Comparator
Other
ActiveComparator Group · 1 Intervention: Active Comparator · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lacosamide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: across the first 48-hours of the treatment period (up to 48 hours)

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
85 Previous Clinical Trials
20,742 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
189 Previous Clinical Trials
43,628 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A written informed consent form is signed by the participant's parent(s) or legal representative(s) and dated
and have a singleton gestation A pregnant woman must be at least 34 weeks of gestational age and have a singleton gestation to participate in the study.
People in the study must have been given either phenobarbital (PB), levetiracetam (LEV), or midazolam (MDZ) before entering the study.
form signed A female participant weighing at least 2.3 kg at the time of enrollment signed the informed consent form.