Recruiting
Phase 2

Levetiracetam

Sponsor:

UCLA

Code:

NCT05610085

Conditions

Neonatal Seizure

Neonatal Encephalopathy

Hypoxic-Ischemic Encephalopathy

Seizure Newborn

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Levetiracetam Injection

Phenobarbital Sodium Injection

Study Details

Brief 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 20 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

Neonatal Seizure

Neonatal Encephalopathy

Hypoxic-Ischemic Encephalopathy

Seizure Newborn

Study ID

NCT05610085

Start date

Mar 24, 2023

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 20 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.

Study Design

Enrollment

133 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose escalation with LEV

Additional LEV at a higher dose (90 mg/kg, 120 mg/kg, or 180 mg/kg in increments depending on the stage of the study).

active comparator: Standard of care Phenobarbital

Treatment with Phenobarbital 20mg/kg IV and if needed a further 20mg/kg totalling 40mg/kg

Interventions

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

Phenobarbital Sodium Injection

Standard of care for neonatal seizures

Primary outcome measure

  • The primary endpoint is the maximum safe and tolerated dose of Levetiracetam [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Sonya G Wang, M.D.

612-301-1454sgwang@umn.edu

Brittany Faanes, MPH

612-625-5929grego318@umn.edu

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92093

Contacts

Jeff Gold, M.D.

jjgold@health.ucsd.edu

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Brittany Faanes, MPH

612-625-5929grego318@umn.edu

Elizabeth Ramey, MS

eramey@umn.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-06-15.