Study Stopped
Study stopped after agreed PIP modification, not linked to safety reasons.
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
LENS
A Multicenter, Open-Label, Randomized, Active Comparator Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
2 other identifiers
interventional
29
3 countries
18
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 minutes of electroencephalographic neonatal seizures (ENS) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (AED) treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2021
Typical duration for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2020
CompletedFirst Posted
Study publicly available on registry
August 20, 2020
CompletedStudy Start
First participant enrolled
March 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedResults Posted
Study results publicly available
October 3, 2025
CompletedOctober 3, 2025
September 1, 2025
3.4 years
July 31, 2020
August 5, 2025
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Seizure Burden Measured in the Evaluation Video-electroencephalogram (Video-EEG) Compared With the Baseline Video-EEG
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 burden measured in the Evaluation video-EEG compared with the Baseline video-EEG was analyzed such that a positive value indicates a reduction in seizure burden from baseline.
During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours), compared to Baseline
Secondary Outcomes (12)
Percentage of Responders in the Evaluation Video-EEG Compared With the Baseline Video-EEG
During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours), compared to Baseline
Percentage of Participants With at Least 80% Reduction in Seizure Burden in the Evaluation a Video-EEG Compared With the Baseline Video-EEG
During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours), compared to Baseline
Time to Response Across the 48-hour Treatment Period Compared With the Baseline Video-EEG
Across the first 48 hours of Treatment Period, compared to Baseline
Time to Seizure Freedom Across the First 48-hour Treatment Period Compared With the Baseline Video-EEG
Across the first 48 hours of Treatment Period, compared to Baseline
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
Treatment Period: 7-8 hours, 15-16 hours, 23-24 hours, 31-32 hours, 39-40 hours, 47-48 hours, compared to Baseline
- +7 more secondary outcomes
Study Arms (2)
Lacosamide
EXPERIMENTALStudy participants randomized to this arm will receive lacosamide (LCM) as an intravenous infusion in the Treatment Period and may continue to receive lacosamide in the Extension Period. Participants should be switched to oral dosing of LCM as soon as medically possible during the Extension Period.
Active Comparator
ACTIVE COMPARATORStudy participants randomized to this arm will receive Active Comparator chosen based on standard of care (StOC) in the Clinical Practice in the Treatment Period and may continue to receive in the Extension Period.
Interventions
Study participants will receive lacosamide (LCM) as an intravenous (iv) infusion during the Treatment Period.
Study participants may receive lacosamide (LCM) as an oral solution during the Extension Period.
Active Comparator treatment will be chosen and dosed based on StOC (per local practice and treatment guidelines).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Sp0968 101
La Jolla, California, 92037, United States
Sp0968 108
Long Beach, California, 90806, United States
Sp0968 116
Los Angeles, California, 90095, United States
Sp0968 190
San Diego, California, 92123, United States
Sp0968 118
Aurora, Colorado, 80045, United States
Sp0968 104
Jacksonville, Florida, 32207, United States
Sp0968 107
Miami, Florida, 33155, United States
Sp0968 112
Iowa City, Iowa, 52242, United States
Sp0968 125
Valhalla, New York, 10595, United States
Sp0968 117
Portland, Oregon, 97239, United States
Sp0968 109
Austin, Texas, 78723, United States
Sp0968 192
Salt Lake City, Utah, 84113, United States
Sp0968 105
Salt Lake City, Utah, 84132, United States
Sp0968 102
Charlottesville, Virginia, 22903, United States
Sp0968 122
Seattle, Washington, 98105, United States
Sp0968 302
Parkville, Australia
Sp0968 301
South Brisbane, Australia
Sp0968 201
Toronto, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study ended prematurely after agreed PIP modification; the termination was not linked to any safety issues/reasons.
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2020
First Posted
August 20, 2020
Study Start
March 31, 2021
Primary Completion
August 6, 2024
Study Completion
October 31, 2024
Last Updated
October 3, 2025
Results First Posted
October 3, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.