Testing Levetiracetam for treating neonatal seizures
A Phase IIb Dose Escalation Study of Levetiracetam for the Treatment of Neonatal Seizures
This study is testing how much of the medication Levetiracetam is safe to give to newborns with seizures to see if it works better than the standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 133 (estimated) |
| Ages | N/A to 1 Month |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 5 sites (San Diego, California and 4 other locations) |
| Trial ID | NCT05610085 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the maximum safe dose of Levetiracetam (LEV) for treating neonatal seizures in infants with mild to moderate seizure burden. It employs an open-label dose-escalation design, where infants will receive increasing doses of LEV, starting from 60mg/kg up to a maximum of 150mg/kg, while being monitored with continuous video EEG. The study also includes a randomized control group receiving Phenobarbital (PHB) to help assess the efficacy and safety of LEV. The primary goal is to establish the recommended maximal safe dose, while secondary aims include studying the pharmacokinetics of LEV and improving seizure detection technologies.
Who should consider this trial
Good fit: Ideal candidates are term neonates at risk for seizures or suspected to be having seizures, weighing more than 2200g and less than 28 days old.
Not a fit: Patients with a cumulative seizure burden of 8 minutes per hour or more, or those with seizures due to correctable metabolic abnormalities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for neonatal seizures, potentially improving outcomes for affected infants.
How similar studies have performed: Other studies have explored the use of Levetiracetam in neonatal seizures, but this specific dose-escalation approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * at risk for seizures or suspected to be having seizures; * all seizure aetiologies except correctable metabolic abnormalities such as hypoglycaemia and hypocalcaemia; * Term neonates (corrected gestational age between 35 and 44 weeks, postnatal age less than 28 days); * weight \> 2200g. * Parental ability to comprehend and provide written informed consent Exclusion Criteria: * Cumulative seizure burden of 8 minutes/ hour or more in phases 1 and 2, Cumulative seizure burden of 30 minutes/hour or more in phase 3; * Renal failure defined as anuria in the first 24 hours of life; * Subjects in whom death seems imminent; * Seizures caused by correctable metabolic abnormality, such as hypocalcaemia, hypoglycaemia.
Where this trial is running
San Diego, California and 4 other locations
- University of California, San Diego — San Diego, California, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Auckland City Hospital — Auckland, Auckland, New Zealand (Recruiting)
- Middlemore Hospital — Auckland, Auckland, New Zealand (Recruiting)
- Capital and Coast District Health Board, Te Whatu Ora, Health New Zealand — Wellington, Wellington Region, New Zealand (Recruiting)
Study contacts
- Principal investigator: Sonya G Wang, M.D. — University of Minnesota
- Study coordinator: Sonya G Wang, M.D.
- Email: sgwang@umn.edu
- Phone: 612-301-1454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.