A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT05610085
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Hypoxic-Ischemic Encephalopathy
  • Neonatal Encephalopathy
  • Neonatal Seizure
  • Seizure Newborn

Eligibility Criteria

Sex
ALL
Age
N/A - 1 Month
Healthy Volunteers
Not accepted

Interventions

  • Levetiracetam Injection — DRUG
    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 — DRUG
    Standard of care for neonatal seizures

Study Details

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

Key Dates

Start date
Mar 24, 2023
Status verified
Oct 2025
Primary completion
Jul 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
133 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation with LEV
    Additional LEV at a higher dose (30 mg/kg, 60 mg/kg, or 90 mg/kg 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

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92093
Jeff Gold, M.D.
[email protected]
University of MinnesotaMinneapolisMinnesota55455
Brittany Faanes, MPH
[email protected]
612-625-5929
Elizabeth Ramey, MS
[email protected]

Find similar trials in San Diego, CA

By research site
University of California, San Diego· San Diego, CAUniversity of Minnesota· Minneapolis, MN

Related Studies