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Antiepileptic
Levetiracetam for Neonatal Seizures (NEOLEV3 Trial)
Phase 2
Recruiting
Led By Jeff J Gold, M.D. PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 years
Awards & highlights
NEOLEV3 Trial Summary
This trial investigates the best dose of Levetiracetam to treat newborns' seizures. It includes a randomized control treatment component and will assess a higher dose of LEV than previously used.
Who is the study for?
This trial is for term neonates (newborns aged less than 28 days) weighing over 2200g, with a variety of seizure causes. It's not for those with severe seizures or correctable metabolic issues like low blood sugar/calcium, or kidney failure.Check my eligibility
What is being tested?
The study tests the safest high dose of Levetiracetam (LEV) for treating newborn seizures compared to Phenobarbital Sodium (PHB). Babies will be monitored and randomly given either LEV or PHB if their seizures continue after an initial LEV dose.See study design
What are the potential side effects?
Possible side effects include sleepiness, changes in behavior, digestive discomfort, and potential allergic reactions. The exact side effects in newborns are being studied as part of this trial.
NEOLEV3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Levetiracetam
Secondary outcome measures
Adverse event rates
Estimate of efficacy of higher dose LEV
Levetiracetam CL
+4 moreNEOLEV3 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dose escalation with LEVExperimental Treatment1 Intervention
Additional LEV at a higher dose (30 mg/kg, 60 mg/kg, or 90 mg/kg depending on the stage of the study).
Group II: Standard of care PhenobarbitalActive Control1 Intervention
Treatment with Phenobarbital 20mg/kg IV and if needed a further 20mg/kg totalling 40mg/kg
Find a Location
Who is running the clinical trial?
Sharp Mary Birch Hospital for Women & NewbornsOTHER
12 Previous Clinical Trials
6,409 Total Patients Enrolled
University of Auckland, New ZealandOTHER
67 Previous Clinical Trials
17,098 Total Patients Enrolled
Middlemore Hospital, New ZealandOTHER
5 Previous Clinical Trials
6,062 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My baby was born full-term and is under 28 days old.My seizures are not caused by treatable issues like low blood sugar or calcium.My newborn had no urine output in the first 24 hours of life.My weight is over 2200 grams.I am at risk for seizures or might be having seizures.My seizures are due to treatable conditions like low calcium or sugar.My seizures last 8 minutes or more per hour in early phases and 30 minutes or more per hour in a later phase.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care Phenobarbital
- Group 2: Dose escalation with LEV
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study looking for more participants?
"Although this study is not presently looking for candidates, clinicaltrials.gov reports that it was last edited on 11/6/2022. There are currently 250 other trials accepting patients."
Answered by AI
How does Dose escalation with LEV impact patients?
"Dose escalation with LEV received a score of 2, as there is only preliminary evidence for its safety and none for efficacy."
Answered by AI
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