Under 28 Days, any sex, with Electroencephalographic Neonatal Seizures or Epilepsy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Seizure Burden Measured in the Evaluation Video-electroencephalogram (Video-EEG) Compared With the Baseline Video-EEGPrimary· During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours), compared to Baseline
Baseline seizure burden was defined as seizure burden measured on the continuous video-EEG (total electroencephalographic neonatal seizures (ENS) in minutes per hour) during a period of up to 2 hours immediately prior to the first administration of study drug. An ENS was defined as an EEG seizure lasting for at least 10 seconds on video-EEG. The seizure burden in the Evaluation Period was calculated as the total duration of seizures between 1 and 3 hours after the first dose of study medication divided by the duration of interpretable video-EEG available in the same period. Change in seizure b
Group
Value
95% CI
Active Comparator
2.45
± 14.83
Lacosamide
6.64
± 6.55
Percentage of Responders in the Evaluation Video-EEG Compared With the Baseline Video-EEGSecondary· During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours), compared to Baseline
A responder is defined as a study participant who achieved the following reduction in seizure burden without need for rescue medication, compared with the seizure burden measured during the Baseline Period immediately prior to the study medication administration, evaluated for a 2-hour period starting 1 hour after the start of initial treatment: - At least 80% reduction of seizure burden in participants who were categorized by the Investigator as having non-severe seizure burden during Baseline OR - At least 50% reduction of seizure burden in participants who were categorized by the Investigat
Group
Value
95% CI
Active Comparator
66.7
Lacosamide
60.0
Percentage of Participants With at Least 80% Reduction in Seizure Burden in the Evaluation a Video-EEG Compared With the Baseline Video-EEGSecondary· During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours), compared to Baseline
A responder is defined as a study participant who achieved the following reduction in seizure burden without need for rescue medication, compared with the seizure burden measured during the Baseline Period immediately prior to investigational medicinal product (IMP) administration, evaluated for a 2-hour period starting 1 hour after the start of initial treatment: A reduction in seizure burden from Baseline of \>=80% regardless of baseline seizure severity. Percentage of Participants With at least 80% Reduction in Seizure Burden in the Evaluation (starting 1 hour after treatment) of a Video-EE
Group
Value
95% CI
Active Comparator
44.4
Lacosamide
60.0
Time to Response Across the 48-hour Treatment Period Compared With the Baseline Video-EEGSecondary· Across the first 48 hours of Treatment Period, compared to Baseline
Time to response where response was defined as a reduction in seizure burden from Baseline of at least 80% in participants with non-severe seizure burden, and of at least 50% for participants with severe seizure burden. Time to response was censored at the date/time the participant received rescue medication or stopped video-EEG monitoring, or otherwise at the end of the 48-hour period.
Group
Value
95% CI
Active Comparator
3.0
3.0 – 8.0
Lacosamide
3.0
NA – NA
Time to Seizure Freedom Across the First 48-hour Treatment Period Compared With the Baseline Video-EEGSecondary· Across the first 48 hours of Treatment Period, compared to Baseline
Seizure freedom was defined as 0 minutes of seizures in a 1-hour period (or 2-hour period for the 3-hour time point) and was analyzed across the 48 hours. The time to seizure freedom was measured in hours, defined as the first time point when the response criterion was met minus the date and time of the first dose of randomized study medication administration. Time to seizure freedom was censored at the time of receiving rescue medication, stopping video-EEG monitoring or otherwise at 48 hours after first dose.
Group
Value
95% CI
Active Comparator
8.0
3.0 – NA
Lacosamide
3.0
NA – NA
Absolute Change in Seizure Burden Across the First 48-hours of the Treatment Period Measured by Continuous Video-EEG Compared With the Baseline Video-EEGSecondary· Treatment Period: 7-8 hours, 15-16 hours, 23-24 hours, 31-32 hours, 39-40 hours, 47-48 hours, compared to Baseline
Baseline seizure burden was calculated as total duration of seizures (in minutes) between -2 hour and 0 hours before first dose of study medication divided by total duration of interpretable video-EEG (in hours) in the same period. Seizure burden for 8, 16, 24, 32, 40 and 48 hour time points was calculated as total duration of seizures in the hour prior to time point divided by duration of interpretable video-EEG available in same period. If \<30 minutes of interpretable video-EEG were available in the 1 hour prior to the time point, response was calculated based on seizure burden for most rec
Treatment, 7 hour - 8 hour
Group
Value
95% CI
Active Comparator
-2.74
± 15.53
Lacosamide
6.30
± 6.74
Treatment, 15 hour - 16 hour
Group
Value
95% CI
Active Comparator
3.63
± 5.28
Lacosamide
7.21
± 6.33
Treatment, 23 hour - 24 hour
Group
Value
95% CI
Active Comparator
5.08
± 4.81
Lacosamide
8.69
± 8.06
Treatment, 31 hour - 32 hour
Group
Value
95% CI
Active Comparator
5.71
± 5.09
Lacosamide
8.93
± 8.56
Treatment, 39 hour - 40 hour
Group
Value
95% CI
Active Comparator
4.43
± 5.80
Lacosamide
8.93
± 8.56
Treatment, 47 hour - 48 hour
Group
Value
95% CI
Active Comparator
4.84
± 5.44
Lacosamide
8.93
± 8.56
Percent Change in Seizure Burden Across the First 48-hours of the Treatment Period Measured by Continuous Video-EEG Compared With the Baseline Video-EEGSecondary· Treatment Period: 7-8 hours, 15-16 hours, 23-24 hours, 31-32 hours, 39-40 hours, 47-48 hours, compared to Baseline
The percent change in seizure burden for the 8, 16, 24, 32, 40 and 48 hour time points was calculated as the seizure burden at Baseline minus the seizure burden at the respective time point, divided by the seizure burden in the Baseline Period, multiplied by 100. Percent change in seizure burden was analyzed such that a positive value indicates a reduction in seizure burden from baseline.
Treatment, 7 hour - 8 hour
Group
Value
95% CI
Active Comparator
39.85
± 147.33
Lacosamide
80.92
± 45.56
Treatment, 15 hour - 16 hour
Group
Value
95% CI
Active Comparator
48.22
± 116.94
Lacosamide
93.19
± 21.53
Treatment, 23 hour - 24 hour
Group
Value
95% CI
Active Comparator
100.00
± 0.00
Lacosamide
99.03
± 3.05
Treatment, 31 hour - 32 hour
Group
Value
95% CI
Active Comparator
100.00
± 0.00
Lacosamide
100.00
± 0.00
Treatment, 39 hour - 40 hour
Group
Value
95% CI
Active Comparator
77.13
± 45.73
Lacosamide
100.00
± 0.00
Treatment, 47 hour - 48 hour
Group
Value
95% CI
Active Comparator
100.00
± 0.00
Lacosamide
100.00
± 0.00
Percentage of Responders at the End of the First 48-hours of the Treatment PeriodSecondary· Across the first 48 hours of Treatment Period
A responder is defined as a study participant who achieved the following reduction in seizure burden without need for rescue medication, compared with the seizure burden measured during the Baseline Period immediately prior to investigational medicinal product (IMP) administration, evaluated for a 2-hour period starting 1 hour after the start of initial treatment: At least 80% reduction of seizure burden in participants who were categorized as having nonsevere seizure burden during Baseline OR At least 50% reduction of seizure burden in participants who had at least one 30-minute period of sev
Group
Value
95% CI
Active Comparator
66.7
Lacosamide
76.9
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 Non Severe or Severe Seizure Burden at BaselineSecondary· 24 hours after the start of Treatment Period, compared to Baseline
Seizure free was defined as 100% reduction in seizure burden or having no seizures in the assessment period (23 to 24 hours after first dose) from Baseline. For the study participants with severe seizure burden at Baseline (as determined by the Investigator), the numerator was defined as the number of participants with severe seizure burden at Baseline who had no seizures between 23 and 24 hours after the start of the Treatment Period. The denominator for the percentages was based on the number of participants with video-EEG data available at the 24 hour time point. Here, N='overall number of
Severe Seizure Burden
Group
Value
95% CI
Active Comparator
33.3
Lacosamide
66.7
Non-severe Seizure Burden
Group
Value
95% CI
Active Comparator
100.0
Lacosamide
62.5
Categorized Percentage of Participants With Change in Seizure Burden in the Evaluation Video-EEG Compared With the Baseline Video-EEGSecondary· During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours), compared to Baseline
Baseline seizure burden was calculated as total duration of seizures (in minutes) between -2 and 0 hours before the first dose of study medication divided by total duration of interpretable video-EEG (in hours) in same period. Seizure burden in Evaluation Period was calculated as total duration of seizures between 1 and 3 hours after first dose of study medication divided by duration of interpretable video-EEG available in same period. Percent change in seizure burden for Evaluation period was calculated as seizure burden at Baseline minus seizure burden at respective time point, divided by se
Evaluation, 1 hour - 3 hour: <-25%
Group
Value
95% CI
Active Comparator
22.2
Lacosamide
0.0
Evaluation, 1 hour - 3 hour: -25% to <25%
Group
Value
95% CI
Active Comparator
0.0
Lacosamide
9.1
Evaluation, 1 hour - 3 hour: 25% to <50%
Group
Value
95% CI
Active Comparator
11.1
Lacosamide
9.1
Evaluation, 1 hour - 3 hour: 50% to <80%
Group
Value
95% CI
Active Comparator
22.2
Lacosamide
0.0
Evaluation, 1 hour - 3 hour: >=80%
Group
Value
95% CI
Active Comparator
44.4
Lacosamide
81.8
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) as Reported by the InvestigatorSecondary· From first administration of study treatment to the End of Safety Follow-up Period (up to Day 42)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. TEAEs are defined as AEs which have onset on or after the start date and time of initial study medication administration.
Group
Value
95% CI
Active Comparator
41.7
Lacosamide
64.3
Percentage of Participants With Treatment-emergent Marked Abnormalities in 12-lead Electrocardiogram (ECG)Secondary· Active Comparator: Screening; Lacosamide: Screening, 1-6 hours, 48 and 96 hours
The ECG treatment-emergent marked abnormalities values are based on grade 2 toxicity based on abnormal values or clinical experience based on investigator's discretion. Participants randomized to Lacosamide and enrolled under this version of the protocol have planned assessments at Screening, 1-6 hours, 48, and 96 hours only. For participants randomized to Active Comparator treatment, only the Screening assessment was applicable.
Screening: Abnormal Clinically significant
Group
Value
95% CI
Active Comparator
0.0
Lacosamide
0.0
1-6 hours: Abnormal Clinically significant
Group
Value
95% CI
Lacosamide
0.0
48 hours: Abnormal Clinically significant
Group
Value
95% CI
Lacosamide
0.0
96 hours: Abnormal Clinically significant
Group
Value
95% CI
Lacosamide
0.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Enrolment: Screening (-36 hours) up to 0 hours (pre-dose); Treatment: From first administration of study treatment to the End of Safety Follow-up (up to Day 42).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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· not yet recruiting
NCT07277660 — A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Stu
· Phase 2
· recruiting
NCT07290036 — A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adu
· Phase 1
· recruiting
NCT07286682 — A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UCB Biopharma SRL
Last refreshed: 3 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04519645.