Improving Treatment for Neonatal Seizures with Levetiracetam
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)
['FUNDING_R01'] · UNIVERSITY OF MINNESOTA · NIH-11161159
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.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | UNIVERSITY OF MINNESOTA (nih funded) |
| Locations | 1 site (MINNEAPOLIS, UNITED STATES) |
| Trial ID | NIH-11161159 on ClinicalTrials.gov |
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.
Who could benefit from this research
Good fit: Ideal candidates are newborns experiencing mild to moderate seizures shortly after birth.
Not a fit: Infants without seizures or those with very severe seizures that require different immediate interventions may not directly benefit from this specific dose escalation.
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 performed: 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
MINNEAPOLIS, UNITED STATES
- UNIVERSITY OF MINNESOTA — MINNEAPOLIS, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: WANG, SONYA GRACE — UNIVERSITY OF MINNESOTA
- Study coordinator: WANG, SONYA GRACE
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.