Efficacy of Intravenous Levetiracetam in Neonatal Seizures (NEOLEV2)
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|ClinicalTrials.gov Identifier: NCT01720667|
Recruitment Status : Completed
First Posted : November 2, 2012
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Seizures||Drug: Intravenous levetiracetam Drug: Intravenous phenobarbital||Phase 1 Phase 2|
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:
- To determine the efficacy of intravenous LEV in terminating neonatal seizures when given as first line therapy.
- To obtain dose escalation data by studying the additional efficacy of a further dose in non responders.
- To obtain additional pharmacokinetic data to confirm findings from our previous pharmacokinetic study.
- To obtain further safety data of LEV in neonates.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||March 2013|
|Actual Primary Completion Date :||October 31, 2017|
|Actual Study Completion Date :||July 31, 2019|
Experimental: Intravenous levetiracetam
Intravenous levetiracetam 40 to 60 mg/kg loading dose. 10 mg/kg 8 hourly maintenance
Drug: Intravenous levetiracetam
Intravenous load of levetiracetam (40 to 60 mg/kg) following identification of EEG confirmed neonatal seizure.
Other Name: Keppra
Active Comparator: Intravenous phenobarbital
Intravenous phenobarbital 20 to 40 mg/kg load. 1.5 mg/kg 8 hourly maintenance
Drug: Intravenous phenobarbital
Intravenous load of phenobarbital (20 to 40 mg/kg) following EEG confirmation of seizure activity load.
Other Name: phenobarbitone
- Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg) [ Time Frame: 24 hours ]
A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures.
Seizure cessation from 15 minutes after completion of infusion for 24 hours as assessed by continuous EEG reviewed by neurophysiologists.
- Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital at 48 Hours After Treatment [ Time Frame: 48 hours ]A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures.
- Number of Neonates With Seizure Termination at 1 Hour After Treatment [ Time Frame: 1 hour ]A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures.
- LEV Dose Escalation Component [ Time Frame: 24 hours ]Number of babies with seizure control at levetiracetam (60 mg/Kg load) who had not responded to 40 mg/kg load and number of babies with seizure control at 40 mg/kg who had not responded to 20 mg/kg.
- Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital Within the Hypoxic Ischemic Encephalopathy (HIE) Population and Treated With Hypothermia [ Time Frame: 24 hours ]
- Pharmacokinetic Data [ Time Frame: 48 hours ]To obtain additional pharmacokinetic data "Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax)" of intravenous levetiracetam to confirm findings from our previous pharmacokinetic study.
- Feasibility of Continuous Internet EEG Monitoring [ Time Frame: Subject study duration ]Feasibility of centralized remote access to continuous video EEG monitoring in the NICU via the internet
- Evaluation of the Accuracy of Neonatal Seizure Detection Algorithm [ Time Frame: 48 Hours ]A novel neonatal seizure detection algorithm will be compared to the gold standard of two encephalographers reading 48 hours of neonatal video EEG in the measurement of seizure burden.
- Gather Safety Information on IV Levetiracetam [ Time Frame: 5 days ]
Safety information to be collected includes daily recording of any adverse events during the 5 day treatment protocol.
Complete Blood Count and Comprehensive Chemistry panels after 48 hours of treatment collected.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720667
|United States, California|
|University of California, San Diego Medical Center / Neonatal Intensive Care Unit (NICU)|
|San Diego, California, United States, 92103|
|Principal Investigator:||Richard H Haas, MD||University of California, San Diego|