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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2020-001066-10
Secondary ID [2] 0 0
SP0968
Universal Trial Number (UTN)
Trial acronym
LENS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in seizure burden measured in the Evaluation video-electroencephalogram (video-EEG) compared with the Baseline video-EEG
Timepoint [1] 0 0
During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours)
Secondary outcome [1] 0 0
Percentage of responders in the Evaluation video-EEG compared with the Baseline video-EEG
Timepoint [1] 0 0
During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours)
Secondary outcome [2] 0 0
Percentage of participants with at least 80% reduction in seizure burden in the Evaluation a video-EEG compared with the Baseline video-EEG
Timepoint [2] 0 0
During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours)
Secondary outcome [3] 0 0
Time to response across the 96-hour Treatment Period
Timepoint [3] 0 0
Across the Treatment Period (up to 96 hours)
Secondary outcome [4] 0 0
Time to seizure freedom across the 96-hour Treatment Period
Timepoint [4] 0 0
Across the Treatment Period (up to 96 hours)
Secondary outcome [5] 0 0
Categorized percentage change in seizure burden in the Evaluation video-EEG compared with the Baseline video-EEG
Timepoint [5] 0 0
During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours)
Secondary outcome [6] 0 0
Percentage of participants with treatment-emergent adverse events (TEAEs) as reported by the investigator
Timepoint [6] 0 0
From first administration of study treatment to the End of Safety Follow-up Period (up to Day 42)
Secondary outcome [7] 0 0
Percentage of participants with treatment-emergent marked abnormalities in 12-lead electrocardiogram (ECG)
Timepoint [7] 0 0
From first administration of study treatment to the End of Safety Follow-up Period (up to Day 42)
Secondary outcome [8] 0 0
Plasma/serum concentration of lacosamide (LCM)
Timepoint [8] 0 0
Across the Treatment Period (up to 96 hours)

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)
Minimum age
No limit
Maximum age
28 Days
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/08/2025
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sp0968 302 - Parkville
Recruitment hospital [2] 0 0
Sp0968 301 - South Brisbane
Recruitment postcode(s) [1] 0 0
- Parkville
Recruitment postcode(s) [2] 0 0
- South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Canada
State/province [15] 0 0
Toronto

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Biopharma SRL
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04519645
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
UCB Cares
Address 0 0
Country 0 0
Phone 0 0
1-844-599-2273 (USA)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04519645