Status:
RECRUITING
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
University of Minnesota
Rady Children's Hospital, San Diego
Conditions:
Neonatal Seizure
Neonatal Encephalopathy
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE2
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 neona...
Detailed Description
Aims/Hypotheses: Primary Aim: To determine the recommended maximal safe dose of LEV in the setting of neonatal seizures of mild to moderate severity. If 60mg/kg LEV does not control seizures, subjec...
Eligibility Criteria
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 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.
Key Trial Info
Start Date :
March 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT05610085
Start Date
March 24 2023
End Date
December 31 2027
Last Update
October 31 2025
Active Locations (5)
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1
University of California, San Diego
San Diego, California, United States, 92093
2
University of Minnesota
Minneapolis, Minnesota, United States, 55455
3
Auckland City Hospital
Auckland, Auckland, New Zealand, 1023
4
Middlemore Hospital
Auckland, Auckland, New Zealand, 1050