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Antiepileptic
Levetiracetam for Neonatal Seizures (NEOLEV3 Trial)
Phase 2
Recruiting
Led By Cynthia M Sharpe, M.D.
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
No Placebo-Only Group
Summary
This trial aims to find the safest and most effective dose of Levetiracetam (LEV) for treating seizures in newborns. LEV works by calming the brain's electrical activity to prevent or reduce seizures. Newborns with seizures will receive LEV, and if seizures continue, they will be given higher doses of LEV. Levetiracetam (LEV) has been studied extensively for its efficacy and safety in treating seizures across various age groups, including neonates, infants, children, and adults.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Levetiracetam
Secondary study objectives
Adverse event rates
Estimate of efficacy of higher dose LEV
Levetiracetam CL
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Levetiracetam, a common treatment for neonatal seizures, works by modulating neurotransmitter release through binding to the synaptic vesicle protein SV2A. This action helps stabilize neuronal activity and prevent seizures.
This mechanism is particularly important for neonatal seizure patients because their developing brains are highly susceptible to excitatory imbalances, which can lead to frequent and severe seizures. By targeting the neurotransmitter release process, Levetiracetam offers a targeted approach to reduce seizure activity with potentially fewer side effects compared to traditional anticonvulsants like phenobarbital, which work by enhancing inhibitory neurotransmission broadly and can have more sedative effects.
Find a Location
Who is running the clinical trial?
Middlemore Hospital, New ZealandOTHER
5 Previous Clinical Trials
6,062 Total Patients Enrolled
Sharp Mary Birch Hospital for Women & NewbornsOTHER
12 Previous Clinical Trials
6,436 Total Patients Enrolled
University of Auckland, New ZealandOTHER
77 Previous Clinical Trials
370,297 Total Patients Enrolled
Rady Children's Hospital, San DiegoOTHER
41 Previous Clinical Trials
14,100 Total Patients Enrolled
Auckland City HospitalOTHER_GOV
19 Previous Clinical Trials
15,386 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,189 Previous Clinical Trials
1,587,608 Total Patients Enrolled
University of MinnesotaOTHER
1,439 Previous Clinical Trials
1,621,825 Total Patients Enrolled
Cynthia M Sharpe, M.D.Principal InvestigatorAuckland City Hospital
Jeff J Gold, M.D. PhDPrincipal InvestigatorUniversity of California, San Diego
Sonya G Wang, M.D.Principal InvestigatorUniversity of Minnesota
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.