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Lacosamide for Neonatal Seizures (LENS Trial)

Phase 2

Recruiting

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant weighs at least 2.3 kg at the time of enrollment Informed consent

Participants must have received either phenobarbital (PB), levetiracetam (LEV), or midazolam (MDZ) (in any combination) before entering the study

Must not have

Participant receiving treatment with phenytoin (PHT), lidocaine (LDC), or other sodium channel blockers at any time

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during 2-hour evaluation starting 1 hour after initial treatment (up to 2 hours)

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the efficacy of lacosamide to an active comparator chosen based on standard of care in reducing seizure burden in neonates with uncontrolled seizures.

Who is the study for?

This trial is for newborns between 34 and <46 weeks of corrected gestational age, weighing at least 2.3 kg, with uncontrolled seizures despite previous treatment with certain anti-epileptic drugs. Newborns must not have seizure causes that are correctable or related to prenatal drug issues.

What is being tested?

The study tests the effectiveness of Lacosamide (LCM), given intravenously or orally, against a standard care comparator in reducing neonatal seizure burden as measured by EEG in newborns whose seizures persist after initial treatments.

What are the potential side effects?

While specific side effects for neonates aren't listed here, Lacosamide in older patients can cause dizziness, headache, nausea, and double vision. Side effects may vary based on individual responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh at least 2.3 kg.

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I have taken phenobarbital, levetiracetam, or midazolam before.

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My baby is between 34 and 46 weeks old in corrected gestational age and less than 28 days old since birth.

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My EEG shows I've had significant neonatal seizures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication like phenytoin or lidocaine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during 2-hour evaluation starting 1 hour after initial treatment (up to 2 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during 2-hour evaluation starting 1 hour after initial treatment (up to 2 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during 2-hour evaluation starting 1 hour after initial treatment (up to 2 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in seizure burden measured in the Evaluation video-electroencephalogram (video-EEG) compared with the Baseline video-EEG

Secondary study objectives

Categorized percentage change in seizure burden in the Evaluation video-EEG compared with the Baseline video-EEG

Percentage of participants with at least 80% reduction in seizure burden in the Evaluation a video-EEG compared with the Baseline video-EEG

Therapeutic procedure

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LacosamideExperimental Treatment2 Interventions

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.

Group II: Active ComparatorActive Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Lacosamide oral

2013

Completed Phase 1

~30

0 / 5Eligibility criteria met