NCT05610085 · University of California, San Diego
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
(NEOLEV3)
What this study 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 gradually increasing doses, preliminary safety and effectiveness study.
View original scientific description
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.
Interventions
DRUG
Levetiracetam Injection
Neonates will be treated with intravenous levetiracetam 60mg/kg for first line management of seizures, and if seizures persist will be randomized to receive higher dose Levetiracetam or standard of care phenobarbital
DRUG
Phenobarbital Sodium Injection
Standard of care for neonatal seizures
Primary outcome measures
The primary endpoint is the maximum safe and tolerated dose of Levetiracetam
Time frame: 4 years
A continual reassessment method will be used to determine the maximal safe and tolerated dose
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Diego, California
- Minneapolis, Minnesota
Collaborators
University of Minnesota, Rady Children's Hospital, San Diego, Auckland City Hospital, University of Auckland, New Zealand, Middlemore Hospital, New Zealand, Waikato Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations