Testing Levetiracetam for treating neonatal seizures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine the maximum safe dose of Levetiracetam (LEV) for treating neonatal seizures in infants with mild to moderate seizure burden. It employs an open-label dose-escalation design, where infants will receive increasing doses of LEV, starting from 60mg/kg up to a maximum of 150mg/kg, while being monitored with continuous video EEG. The study also includes a randomized control group receiving Phenobarbital (PHB) to help assess the efficacy and safety of LEV. The primary goal is to establish the recommended maximal safe dose, while secondary aims include studying the pharmacokinetics of LEV and improving seizure detection technologies.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting
• Auckland City Hospital
  Auckland, Auckland, New Zealand Recruiting
• Middlemore Hospital
  Auckland, Auckland, New Zealand Recruiting
• Health New Zealand, Te Whatu Ora - Waikato Hospital
  Hamilton, Waikato Region, New Zealand Recruiting
• Capital and Coast District Health Board, Te Whatu Ora, Health New Zealand
  Wellington, Wellington Region, New Zealand Recruiting
• University of California, San Diego
  San Diego, California, United States Completed

Study contacts

• Principal investigator: Sonya G Wang, M.D. — University of Minnesota
• Study coordinator: Sonya G Wang, M.D.
• Email: sgwang@umn.edu
• Phone: 612-301-1454

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.