NCT02550028

Levetiracetam Treatment of Neonatal Seizures

Levetiracetam Treatment of Neonatal Seizures: A Multi-Centre Randomized Blinded Controlled Study of the Efficacy of Oral Levetiracetam as First Line Treatment for Neonatal Seizures in China

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

Summary

Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. A multi-centre Chinese clinical trials with the aim to using oral Levetiracetam to develop new treatment strategies for the treatment of neonatal seizures. The purpose of this study is to determine the correct oral dosing, safety and efficacy for oral Levetiracetam as first line treatment in term new born babies with seizures.

Detailed description

This project aims to improve the treatment of neonatal seizures. Current treatments are poorly effective and have significant side effects. Levetiracetam has great potential as a treatment for neonatal seizures but is not approved for use in children less than 1 years of age by oral. This study aims to obtain essential data regarding the efficacy and safety of oral Levetiracetam in neonatal population and simultaneously to use EEG monitoring systems that facilitate seizure detection and research. Specific aims are: 1. To determine the efficacy of oral Levetiracetam in terminating neonatal seizures by EEG in the Neonatal Neurological Intensive Care Unit (NNICU). 2. To determine dose escalation data by studying the additional efficacy of a further dose in non responders. 3. To determine additional pharmacokinetic data to confirm findings from our previous pharmacokinetic study. 4. To determine further safety data of oral Levetiracetam in neonates.

Conditions

• Neonatal Seizures

Interventions

Type	Name	Description
DRUG	Oral levetiracetam	Oral load of levetiracetam (50 mg/kg) following identification of EEG confirmed neonatal seizure.
DRUG	Intravenous phenobarbital	Intravenous load of phenobarbital (20 mg/kg)following EEG confirmation of seizure activity load.

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-09-15
• Last updated: 2023-12-29

Locations

1 site across 1 country: China