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NCT05610085 · ClinicalTrials.gov registry record · Phase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
A Phase 2 study of Hypoxic Ischemic Encephalopathy and Neonatal Encephalopathy, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 133
- Enrollment target
- 5
- Study locations
NCT05610085: Recruiting Phase 2 study of Hypoxic Ischemic Encephalopathy and Neonatal Encephalopathy, sponsored by University of California, San Diego.
NCT05610085 is a Phase 2 study of Hypoxic Ischemic Encephalopathy and Neonatal Encephalopathy that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 133 participants, above the 73-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (82% higher). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05610085, a Phase 2 study of Hypoxic Ischemic Encephalopathy and Neonatal Encephalopathy, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 133 participants
- Enrollment target
- 5
- Study locations
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
Primary Outcome
A continual reassessment method will be used to determine the maximal safe and tolerated dose
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 |
What NCT05610085 shows while recruiting
NCT05610085 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, above the 73-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (82% higher).
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.
NCT05610085 lists 5 locations in 4 states (Auckland, California, Minnesota).
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.
What interventions are being tested in trial NCT05610085?
The interventions under investigation include: Levetiracetam Injection (DRUG), Phenobarbital Sodium Injection (DRUG).
Who is sponsoring clinical trial NCT05610085?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Hypoxic Ischemic Encephalopathy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05610085's enrollment target sits among peer trials
133 3rd of 13 higher than 11 of 13 other Hypoxic Ischemic Encephalopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoxic Ischemic Encephalopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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