Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study

Launched by UNIVERSITY HOSPITAL, TOURS · Aug 28, 2014

Keywords

ClinConnect Summary

Article Focus

* The principal aim of LEVNEONAT-1 is to determine the levetiracetam optimal dose defined as the highest efficient dose under toxicity restrictions for treating neonatal seizures.
* LEVNEONAT-1 is an open-label, sequential dose-finding study with 3 increasing dose levels of levetiracetam.

Strenghts and limitation of study

* For the first time, levetiracetam will be used as the first-line treatment of neonatal seizures and not as an add-on therapy.
* Statistical model is designed for a rare clinical situation with a sequential adaptive method updating in real time the dose a...

Gender

ALL

Eligibility criteria

• Eligibility Criteria:
• • 1. Male or female term baby with gestational age of 36-43 weeks and postnatal age \< or= 72 hours
• 2. One or more of the following :
• • APGAR score \< 5 at 5 mins
• • Umbilical cord or arterial blood sample (within one hour after birth): pH \<7.0 or base deficit \> or = 16 mmol/L or lactates \> or equal to 11 mmol/L
• • Abnormal neurological examination before 6 hours of life
• • 3. Suspected clinical or EEG seizures
• Inclusion criteria:
• • A seizure lasting more than 3 minutes or more than 2 seizures lasting more than 20 seconds on a 1 hour-period on standard EEG recording 4 hours before the levetiracetam loading dose
• • Availability of 8 electrode EEG recording
• • Written informed consent of both parents or the authorized guardians
• • Subscription to social security health insurance are required
• Exclusion Criteria:
• • Suspected or confirmed brain malformation, inborn error of metabolism, genetic syndrome or major congenital malformation
• • Congenital (in utero) infection (TORCH)
• • Babies who have received phenobarbital or any other anticonvulsive medication other than a bolus of midazolam for intubation
• • Anuria/renal failure defined as serum creatinine \> 150 micromol/L
• • Seizures secondary to treatable metabolic etiology as hypoglycemia and hypocalcemia
• • Corrected QT interval (QTc) greater than 450 milliseconds on the electrocardiogram (ECG) prior to inclusion in the presence or absence of a condition that promotes QT prolongation (hypokalemia, maternal treatment during childbirth or treatment of the child with drugs known to prolong QT),
• • Participation to an interventional research study