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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04519645
Registration number
NCT04519645
Ethics application status
Date submitted
31/07/2020
Date registered
20/08/2020
Date last updated
9/05/2024
Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
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Scientific title
A Multicenter, Open-Label, Randomized, Active Comparator Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
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Secondary ID [1]
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2020-001066-10
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Secondary ID [2]
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SP0968
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Universal Trial Number (UTN)
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Trial acronym
LENS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Electroencephalographic Neonatal Seizures
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Epilepsy
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Condition category
Condition code
Neurological
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Epilepsy
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Lacosamide intravenous
Treatment: Drugs - Lacosamide oral
Other interventions - Active Comparator
Experimental: Lacosamide - Study 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 Comparator - Study 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.
Treatment: Drugs: Lacosamide intravenous
Study participants will receive lacosamide (LCM) as an intravenous (iv) infusion during the Treatment Period.
Treatment: Drugs: Lacosamide oral
Study participants may receive lacosamide (LCM) as an oral solution during the Extension Period.
Other interventions: Active Comparator
Active Comparator treatment will be chosen and dosed based on StOC (per local practice and treatment guidelines).
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in seizure burden measured in the Evaluation video-electroencephalogram (video-EEG) compared with the Baseline video-EEG
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Assessment method [1]
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Change in seizure burden measured in the Evaluation video-EEG compared with the Baseline video-EEG.
Baseline seizure burden is 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.
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Timepoint [1]
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During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours)
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Secondary outcome [1]
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Percentage of responders in the Evaluation video-EEG compared with the Baseline video-EEG
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Assessment method [1]
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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 severe seizure burden during Baseline
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Timepoint [1]
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During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours)
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Secondary outcome [2]
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Percentage of participants with at least 80% reduction in seizure burden in the Evaluation a video-EEG compared with the Baseline video-EEG
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Assessment method [2]
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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 severe seizure burden during Baseline
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Timepoint [2]
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During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours)
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Secondary outcome [3]
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Time to response across the 96-hour Treatment Period
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Assessment method [3]
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Time to response is presented as median time (in hours) to the 50% reduction in study participants with severe seizure burden or 80% reduction in study participants with nonsevere seizure burden.
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Timepoint [3]
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Across the Treatment Period (up to 96 hours)
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Secondary outcome [4]
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Time to seizure freedom across the 96-hour Treatment Period
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Assessment method [4]
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Time to seizure freedom will be analyzed as median time (in hours) to seizure freedom.
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Timepoint [4]
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Across the Treatment Period (up to 96 hours)
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Secondary outcome [5]
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Categorized percentage change in seizure burden in the Evaluation video-EEG compared with the Baseline video-EEG
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Assessment method [5]
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The change in seizure burden will be presented in the following categories: (<-25% [worsening], -25% to <25% [no change], 25% to <50%, 50% to <80%, and =80%)
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Timepoint [5]
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During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours)
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Secondary outcome [6]
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Percentage of participants with treatment-emergent adverse events (TEAEs) as reported by the investigator
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Assessment method [6]
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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.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
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Timepoint [6]
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From first administration of study treatment to the End of Safety Follow-up Period (up to Day 42)
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Secondary outcome [7]
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Percentage of participants with treatment-emergent marked abnormalities in 12-lead electrocardiogram (ECG)
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Assessment method [7]
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Marked abnormalities are defined as abnormalities in predefined parameters based upon grade 2 toxicity lab values and neonatologist expert opinion in the neonate.
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Timepoint [7]
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From first administration of study treatment to the End of Safety Follow-up Period (up to Day 42)
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Secondary outcome [8]
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Plasma/serum concentration of lacosamide (LCM)
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Assessment method [8]
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Mean plasm/serum concentrations of lacosamide (LCM) will be presented across the Treatment Period.
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Timepoint [8]
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Across the Treatment Period (up to 96 hours)
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Eligibility
Key inclusion criteria
- 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)
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Minimum age
No limit
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Maximum age
28
Days
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/08/2025
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Actual
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Sample size
Target
32
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sp0968 302 - Parkville
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Recruitment hospital [2]
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Sp0968 301 - South Brisbane
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Recruitment postcode(s) [1]
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- Parkville
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Recruitment postcode(s) [2]
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- South Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Colorado
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United States of America
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State/province [3]
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Connecticut
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Country [4]
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United States of America
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Florida
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Country [5]
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United States of America
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Iowa
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Country [6]
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United States of America
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State/province [6]
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Minnesota
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Country [7]
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United States of America
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New York
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Country [8]
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United States of America
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State/province [8]
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North Carolina
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Country [9]
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United States of America
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State/province [9]
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Oregon
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
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State/province [14]
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Washington
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Country [15]
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Canada
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State/province [15]
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Toronto
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
UCB Biopharma SRL
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04519645
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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UCB Cares
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Address
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001 844 599 2273
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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UCB Cares
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Address
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Phone
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1-844-599-2273 (USA)
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04519645
Download to PDF