A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
NCT ID: NCT04519645
Last Updated: 2025-10-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
29 participants
INTERVENTIONAL
2021-03-31
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Lacosamide intravenous
Study participants will receive lacosamide (LCM) as an intravenous (iv) infusion during the Treatment Period.
Lacosamide oral
Study participants may receive lacosamide (LCM) as an oral solution during the Extension Period.
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.
Active Comparator
Active Comparator treatment will be chosen and dosed based on StOC (per local practice and treatment guidelines).
Interventions
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Active Comparator
Active Comparator treatment will be chosen and dosed based on StOC (per local practice and treatment guidelines).
Lacosamide intravenous
Study participants will receive lacosamide (LCM) as an intravenous (iv) infusion during the Treatment Period.
Lacosamide oral
Study participants may receive lacosamide (LCM) as an oral solution during the Extension Period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
28 Days
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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Sp0968 101
La Jolla, California, United States
Sp0968 108
Long Beach, California, United States
Sp0968 116
Los Angeles, California, United States
Sp0968 190
San Diego, California, United States
Sp0968 118
Aurora, Colorado, United States
Sp0968 104
Jacksonville, Florida, United States
Sp0968 107
Miami, Florida, United States
Sp0968 112
Iowa City, Iowa, United States
Sp0968 125
Valhalla, New York, United States
Sp0968 117
Portland, Oregon, United States
Sp0968 109
Austin, Texas, United States
Sp0968 192
Salt Lake City, Utah, United States
Sp0968 105
Salt Lake City, Utah, United States
Sp0968 102
Charlottesville, Virginia, United States
Sp0968 122
Seattle, Washington, United States
Sp0968 302
Parkville, , Australia
Sp0968 301
South Brisbane, , Australia
Sp0968 201
Toronto, , Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-001066-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0968
Identifier Type: -
Identifier Source: org_study_id
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