Actively Recruiting
A Phase IIb Dose Escalation Study of Levetiracetam for the Treatment of Neonatal Seizures
Led by University of California, San Diego · Updated on 2025-10-31
133
Participants Needed
5
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
U
University of Minnesota
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the maximum safe dose of Levetiracetam (LEV) for treating seizures in newborns. This Phase IIb study focuses on infants with mild to moderate neonatal seizures, hypothesizing that the optimal dose is higher than the current 60 mg/kg. The research also explores LEV's safety, tolerability, and its effectiveness compared to the standard treatment, Phenobarbital (PHB). Participants initially receive 60 mg/kg of LEV. If seizures continue after 15 minutes, they may be randomly assigned to receive either higher doses of LEV (in increments up to 150 mg/kg total) or PHB treatment at 20-40 mg/kg. The study uses continuous video EEG monitoring to measure seizure activity and evaluate the treatments. The trial includes multiple phases and dose escalation to ensure safety and gather efficacy data. During the study, infants will undergo continuous EEG monitoring to assess seizure burden over 24 hours, with neurophysiologists reviewing the data. Researchers will track LEV blood levels, adverse events, seizure reduction, and long-term outcomes up to 8 years. The study also evaluates a seizure detection technology. Participation involves treatment administration, monitoring, and follow-up to assess safety and seizure control.
CONDITIONS
Brief Title
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At risk for seizures or suspected to be having seizures
- All seizure causes except correctable metabolic abnormalities like low blood sugar or low calcium
- Term neonates with corrected gestational age between 35 and 44 weeks and postnatal age less than 28 days
- Weight greater than 2200 grams
- Parent or guardian able to understand and provide written informed consent
You will not qualify if you...
- Seizure burden of 8 minutes per hour or more in phases 1 and 2, or 30 minutes per hour or more in phase 3
- Renal failure defined as no urine output in the first 24 hours of life
- Infants with a likely imminent death
- Seizures caused by correctable metabolic abnormalities such as hypocalcaemia or hypoglycaemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 5 days
Participants receive intravenous Levetiracetam 60 mg/kg as first-line treatment for neonatal seizures. If seizures persist, participants are randomized to receive higher dose Levetiracetam or Phenobarbital treatment. Maintenance treatment continues for 5 days either intravenously or orally if feeding is tolerated.
1 initial treatment visit and daily visits during maintenance treatment
Duration - Up to 8 years
Participants are monitored for safety, seizure control, and long-term outcomes after treatment.
Periodic follow-up visits over several years
Trial Site Locations
Total: 5 locations
1
University of California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
2
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
3
Auckland City Hospital
Auckland, Auckland, New Zealand, 1023
Actively Recruiting
4
Middlemore Hospital
Auckland, Auckland, New Zealand, 1050
Actively Recruiting
5
Capital and Coast District Health Board, Te Whatu Ora, Health New Zealand
Wellington, Wellington Region, New Zealand, 6021
Actively Recruiting
Research Team
S
Sonya G Wang, M.D.
B
Brittany Faanes, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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