Actively Recruiting
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Led by University of California, San Diego · Updated on 2025-10-31
133
Participants Needed
5
Research Sites
249 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
The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly greater than 60mg/kg. This study will be an open label dose-escalation, preliminary safety and efficacy study. There will be a randomized control treatment component. Infants recognized as having neonatal seizures or as being at risk of developing seizures will be recruited and started on continuous video EEG monitoring (CEEG). Eligibility will be confirmed and consent will be obtained. In the first 2 phases of the study, neurologists will identify neonates with mild-moderate seizure burden (less than 8 minutes cumulative seizure activity per hour), appropriate for study with LEV, and exclude patients with higher seizure burden where treatment with PHB is more appropriate. Phase 3 of the dose escalation will only proceed if additional efficacy of LEV has been demonstrated in phases 1 and 2. In Phase 3 we will recruit neonates with seizures of greater severity up to 30 minute seizure burden/hour. This will make the final results of study more generalizable. If seizures are confirmed, enrolled subjects will receive 60mg/kg of LEV. Subjects whose seizures persist or recur 15 minutes after the first infusion is complete, subjects will then be randomized in the dose escalation study. Patients in the dose escalation study will be randomly assigned to receive either higher dose LEV or treatment with the control drug PHB in a 3:1 allocation ratio, stratified by site. Funding Source- FDA OOPD
CONDITIONS
Official 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 hypoglycaemia and hypocalcaemia
- Term neonates with corrected gestational age between 35 and 44 weeks and postnatal age less than 28 days
- Weight greater than 2200 grams
- Parents 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
- Babies in whom death seems imminent
- 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
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.
CONTACT
B
Brittany Faanes, MPH
CONTACT
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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