NIH-funded research R01 grant

Improving Treatment for Neonatal Seizures with Levetiracetam

Official title: NEOLEV3: A Phase IIb Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures of Mild to Moderate Severity IND-109622 (September 6, 2020)

Funded at University of Minnesota · NIH-11161159 · Data updated 2026-11-12

This project aims to find the best dose of a medication called Levetiracetam to help babies who have mild to moderate seizures shortly after birth.

More Seizures research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionUniversity of Minnesota
NIH-funded
Lab location1 site (Minneapolis, United States)
Project startSeptember 20, 2022
Project endJuly 31, 2027
Funding year2025
Award (this year)$703,432
NIH project number5R01FD006335-03
Project IDNIH-11161159 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates are newborns experiencing mild to moderate seizures shortly after birth.

Less likely to help

Infants without seizures or those with very severe seizures that require different immediate interventions may not directly benefit from this specific dose escalation.

What this research studies

Neonatal seizures affect many infants, and survivors often face long-term disabilities like cerebral palsy and developmental delays. Current treatments like phenobarbital can control seizures but may cause unwanted side effects such as breathing problems or sedation, and there are concerns about long-term brain development. This project is testing a different medication, Levetiracetam, which has shown fewer side effects, to see if a higher dose can safely and effectively reduce seizures in babies. The goal is to find a better, gentler way to treat these seizures, especially for those with mild to moderate severity.

Why it matters

Potential benefit: If successful, this could lead to a safer and more effective treatment option for newborns experiencing seizures, potentially improving their long-term brain development.

How similar studies have gone: A previous clinical trial (NEOLEV2) compared Levetiracetam to phenobarbital, showing phenobarbital had greater seizure control but also more acute side effects, indicating a need to refine Levetiracetam's use.

Where this research is happening

  • University of Minnesota
    Minneapolis, United States
    Active

Researchers

  • Principal investigator: Wang, Sonya Grace — University of Minnesota
  • Study coordinator: Wang, Sonya Grace

Related research

Other NIH-funded projects on the same topics.

  • Pediatric EMS seizures: simpler age-based midazolam dosing

    A nationwide trial at EMS agencies tests whether using fixed, age-based dosing of midazolam for seizures in children improves treatment speed and safety.

    NIH research Stanford University · Stanford, United States · NIH-11617686

  • Gene editing therapies to prevent epileptic seizures

    A new gene-editing approach aims to reduce seizures in people with epilepsy by directly modifying a brain gene tied to the condition.

    NIH research University of Texas Hlth Science Center · San Antonio, United States · NIH-11605225

  • Detecting Absence Seizures in Kids at Home with a Mobile Recorder

    A new mobile app helps doctors remotely diagnose and monitor childhood absence epilepsy using guided hyperventilation and video analysis to speed up treatment.

    NIH research Eysz, INC. · Berkeley, UNITED STATES · NIH-11584327

  • Seizures and long-term outcomes after childhood stroke

    This project looks at whether early seizures and inflammation after a childhood stroke are linked to later epilepsy and recovery in kids up to 19 years old.

    NIH research University of California, San Francisco · San Francisco, United States · NIH-11474008

  • Using the brain’s natural connector to detect and prevent seizures

    A study at Case Western Reserve University is exploring whether gently stimulating a natural brain pathway called the corpus callosum can help identify where seizures start and stop them from spreading in people with hard-to-control epilepsy.

    NIH research Case Western Reserve University · Cleveland, United States · NIH-11449578

  • Disentangling How Inhibitory Brain Cells Shape Seizures in People

    This NIH grant tests how specific brain cells that normally calm the brain influence seizures in adults, using advanced optical methods in living subjects.

    NIH research Baylor College of Medicine · Houston, United States · NIH-11448856

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.