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A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
NCT05610085 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG Levetiracetam Injection
- DRUG Phenobarbital Sodium Injection
Study Locations (5)
Auckland
- Auckland City Hospital — Auckland
- Middlemore Hospital — Auckland
California
- University of California, San Diego — San Diego
Minnesota
- University of Minnesota — Minneapolis
Wellington Region
- Capital and Coast District Health Board, Te Whatu Ora, Health New Zealand — Wellington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2023-03-24 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05610085
The ClinicalTrials.gov registry entry for NCT05610085 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 823 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Hypoxic-Ischemic Encephalopathy appearing as the primary indexed condition, and to 2 interventions — of which Levetiracetam Injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05610085 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Auckland, California, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05610085 about?
NCT05610085 is a clinical study titled "A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures". 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...
What is the current status of trial NCT05610085?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 133 participants. The study started on 2023-03-24. Estimated completion is 2027-12-31.
What conditions does trial NCT05610085 study?
This clinical trial studies the following conditions: Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy, Neonatal Seizure, Seizure Newborn. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05610085?
The interventions under investigation include: Levetiracetam Injection (DRUG), Phenobarbital Sodium Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05610085?
This trial is sponsored by University of California, San Diego, which has 823 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05610085 being conducted?
This trial has 5 study locations across California, Minnesota, Auckland, Wellington Region. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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