Clinical trial NCT04519645: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Electroencephalographic Neonatal Seizures
Epilepsy
Keywords: electroencephalographic neonatal seizures
epilepsy
neonatal study participants
Vimpat
lacosamide
LCM
pediatric
video-EEG
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2020-08-20
Enrollment: 29
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

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

Primary outcomes:
measure: Change in seizure burden measured in the Evaluation video-electroencephalogram (video-EEG) compared with the Baseline video-EEG
timeFrame: During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours)
Secondary outcomes:
measure: Percentage of responders in the Evaluation video-EEG compared with the Baseline video-EEG
timeFrame: During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours)
measure: Percentage of participants with at least 80% reduction in seizure burden in the Evaluation a video-EEG compared with the Baseline video-EEG
timeFrame: During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours)
measure: Time to response across the 96-hour Treatment Period
timeFrame: Across the Treatment Period (up to 96 hours)
measure: Time to seizure freedom across the 96-hour Treatment Period
timeFrame: Across the Treatment Period (up to 96 hours)
measure: Categorized percentage change in seizure burden in the Evaluation video-EEG compared with the Baseline video-EEG
timeFrame: During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours)
measure: Percentage of participants with treatment-emergent adverse events (TEAEs) as reported by the investigator
timeFrame: From first administration of study treatment to the End of Safety Follow-up Period (up to Day 42)
measure: Percentage of participants with treatment-emergent marked abnormalities in 12-lead electrocardiogram (ECG)
timeFrame: From first administration of study treatment to the End of Safety Follow-up Period (up to Day 42)
measure: Plasma/serum concentration of lacosamide (LCM)
timeFrame: Across the Treatment Period (up to 96 hours)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Sp0968 101
state: California
city: Long Beach
country: United States
facility: Sp0968 108
state: California
city: Los Angeles
country: United States
facility: Sp0968 116
state: California
city: San Diego
country: United States
facility: Sp0968 190
state: California
city: Aurora
country: United States
facility: Sp0968 118
state: Colorado
city: Jacksonville
country: United States
facility: Sp0968 104
state: Florida
city: Miami
country: United States
facility: Sp0968 107
state: Florida
city: Iowa City
country: United States
facility: Sp0968 112
state: Iowa
city: Valhalla
country: United States
facility: Sp0968 125
state: New York
city: Portland
country: United States
facility: Sp0968 117
state: Oregon
city: Austin
country: United States
facility: Sp0968 109
state: Texas
city: Salt Lake City
country: United States
facility: Sp0968 192
state: Utah
city: Salt Lake City
country: United States
facility: Sp0968 105
state: Utah
city: Charlottesville
country: United States
facility: Sp0968 102
state: Virginia
city: Seattle
country: United States
facility: Sp0968 122
state: Washington
city: Parkville
country: Australia
facility: Sp0968 302
city: South Brisbane
country: Australia
facility: Sp0968 301
city: Toronto
country: Canada
facility: Sp0968 201
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: