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

Description

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

Conditions

Neonatal Seizure, Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Seizure Newborn

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Study Overview

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Study Details

Study overview

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

A Phase IIb Dose Escalation Study of Levetiracetam for the Treatment of Neonatal Seizures

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

Condition
Neonatal Seizure
Intervention / Treatment

-

Contacts and Locations

San Diego

University of California, San Diego, San Diego, California, United States, 92093

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Cumulative seizure burden of 8 minutes/ hour or more in phases 1 and 2, Cumulative seizure burden of 30 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.

Ages Eligible for Study

to 1 Month

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Diego,

Sonya G Wang, M.D., PRINCIPAL_INVESTIGATOR, University of Minnesota

Cynthia M Sharpe, M.D., PRINCIPAL_INVESTIGATOR, Auckland City Hospital

Jeff J Gold, M.D. PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Richard H Haas, MBBChir, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

2027-12-31