NCT01720667

Efficacy of Intravenous Levetiracetam in Neonatal Seizures

Efficacy of Intravenous Levetiracetam in Neonatal Seizures: A Phase 2 Randomized Blinded Controlled Study of the Efficacy of Intravenous Levetiracetam (LEV) as First Line Treatment for Neonatal Seizures

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Richard H. Haas · Academic / Other
• Sex: All
• Age: 15 Minutes – 14 Days
• Healthy volunteers: Not accepted

Summary

A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants. Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. Monitoring for seizure detection will be tested at five (5) US sites and one (1) international site using the internet.

Detailed description

This project aims to improve the treatment of neonatal seizures. Current treatments are poorly effective and have significant side effects. Levetiracetam (LEV) has great potential as a treatment for neonatal seizures but is not approved for use in children less than 2 years of age. This study aims to obtain essential data regarding the efficacy and safety of LEV in this vulnerable and under researched population and simultaneously to develop EEG monitoring systems that facilitate seizure detection and research. Specific aims are: 1. To determine the efficacy of intravenous LEV in terminating neonatal seizures when given as first line therapy. 2. To obtain dose escalation data by studying the additional efficacy of a further dose in non responders. 3. To obtain additional pharmacokinetic data to confirm findings from our previous pharmacokinetic study. 4. To obtain further safety data of LEV in neonates. 5. To prove the feasibility of centralized remote monitoring of continuous EEG monitoring in the Neonatal Intensive Care Unit (NICU) via the internet and test a promising automated neonatal seizure detection algorithm. The study design is a phase 2b randomized blinded controlled study.

Conditions

• Neonatal Seizures

Interventions

Type	Name	Description
DRUG	Intravenous levetiracetam	Intravenous load of levetiracetam (40 to 60 mg/kg) following identification of EEG confirmed neonatal seizure.
DRUG	Intravenous phenobarbital	Intravenous load of phenobarbital (20 to 40 mg/kg) following EEG confirmation of seizure activity load.

Timeline

• Start date: 2013-03-01
• Primary completion: 2017-10-31
• Completion: 2019-07-31
• First posted: 2012-11-02
• Last updated: 2019-08-21
• Results posted: 2019-08-21

Locations

1 site across 1 country: United States