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New drug tested for newborn seizures – but trial halted early

NCT ID NCT04519645

Disease control Sponsor: UCB Biopharma SRL Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the drug lacosamide in newborns with repeated seizures that were not controlled by standard medicines. The trial was small (29 babies) and was stopped early. Researchers compared lacosamide to usual care to see if it could reduce seizure time on brain monitoring.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lacosamide
What this could lead to
If it works, this could point toward a new treatment option for seizures in newborns that are not controlled by other medicines.
What could go wrong
This was a small, early-stage trial that was terminated, so results are limited. It is unclear if lacosamide is safe or effective for this use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

29 people

The number who actually took part.

Started

Mar 2021

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 28 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Electroencephalographic neonatal seizures Epilepsy

Contacts and locations

Locations

  • Sp0968 101

    La Jolla, California, 92037, United States

  • Sp0968 102

    Charlottesville, Virginia, 22903, United States

  • Sp0968 104

    Jacksonville, Florida, 32207, United States

  • Sp0968 105

    Salt Lake City, Utah, 84132, United States

  • Sp0968 107

    Miami, Florida, 33155, United States

  • Sp0968 108

    Long Beach, California, 90806, United States

  • Sp0968 109

    Austin, Texas, 78723, United States

  • Sp0968 112

    Iowa City, Iowa, 52242, United States

  • Sp0968 116

    Los Angeles, California, 90095, United States

  • Sp0968 117

    Portland, Oregon, 97239, United States

  • Sp0968 118

    Aurora, Colorado, 80045, United States

  • Sp0968 122

    Seattle, Washington, 98105, United States

  • Sp0968 125

    Valhalla, New York, 10595, United States

  • Sp0968 190

    San Diego, California, 92123, United States

  • Sp0968 192

    Salt Lake City, Utah, 84113, United States

  • Sp0968 201

    Toronto, Canada

  • Sp0968 301

    South Brisbane, Australia

  • Sp0968 302

    Parkville, Australia

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