NCT01720667

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
21 days until next milestone

Results Posted

Study results publicly available

August 21, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

4.7 years

First QC Date

October 22, 2012

Results QC Date

July 3, 2019

Last Update Submit

August 12, 2019

Conditions

Neonatal Seizures

Keywords

SeizuresNeonatesAnticonvulsantsTreatmentLevetiracetamPhenobarbital

Outcome Measures

Primary Outcomes (1)

  • Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg)

    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.

    24 hours

Secondary Outcomes (4)

  • Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital at 48 Hours After Treatment

    48 hours

  • Number of Neonates With Seizure Termination at 1 Hour After Treatment

    1 hour

  • LEV Dose Escalation Component

    24 hours

  • 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

    24 hours

Other Outcomes (4)

  • Pharmacokinetic Data

    48 hours

  • Feasibility of Continuous Internet EEG Monitoring

    Subject study duration

  • Evaluation of the Accuracy of Neonatal Seizure Detection Algorithm

    48 Hours

  • +1 more other outcomes

Study Arms (2)

Intravenous levetiracetam

EXPERIMENTAL

Intravenous levetiracetam 40 to 60 mg/kg loading dose. 10 mg/kg 8 hourly maintenance

Drug: Intravenous levetiracetam

Intravenous phenobarbital

ACTIVE COMPARATOR

Intravenous phenobarbital 20 to 40 mg/kg load. 1.5 mg/kg 8 hourly maintenance

Drug: Intravenous phenobarbital

Interventions

Intravenous levetiracetamDRUG

Intravenous load of levetiracetam (40 to 60 mg/kg) following identification of EEG confirmed neonatal seizure.

Also known as: Keppra
Intravenous levetiracetam
Intravenous phenobarbitalDRUG

Intravenous load of phenobarbital (20 to 40 mg/kg) following EEG confirmation of seizure activity load.

Also known as: phenobarbitone
Intravenous phenobarbital

Eligibility Criteria

Age15 Minutes - 14 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Newborns admitted to any of the study sites with electrographic seizures seizures.
  • Term infants gestational age \>36 weeks less than 2 weeks of age.
  • Greater than 2200 grams.
  • Infants for whom parental consent to participate in the study is obtained.

You may not qualify if:

  • Infants who are already receiving anticonvulsants
  • If serum creatinine is greater than 1.6mM
  • If seizures are due to correctable metabolic abnormalities (i.e. hypoglycaemia, hypocalcemia, hyponatremia)
  • Subjects in whom death seems imminent, as assessed by the neonatologist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego Medical Center / Neonatal Intensive Care Unit (NICU)

San Diego, California, 92103, United States

Location

Related Publications (3)

  • Sharpe CM, Capparelli EV, Mower A, Farrell MJ, Soldin SJ, Haas RH. A seven-day study of the pharmacokinetics of intravenous levetiracetam in neonates: marked changes in pharmacokinetics occur during the first week of life. Pediatr Res. 2012 Jul;72(1):43-9. doi: 10.1038/pr.2012.51. Epub 2012 Apr 11.

    PMID: 22495532BACKGROUND

  • Sharpe C, Davis SL, Reiner GE, Lee LI, Gold JJ, Nespeca M, Wang SG, Joe P, Kuperman R, Gardner M, Honold J, Lane B, Knodel E, Rowe D, Battin MR, Bridge R, Goodmar J, Castro B, Rasmussen M, Arnell K, Harbert M, Haas R. Assessing the Feasibility of Providing a Real-Time Response to Seizures Detected With Continuous Long-Term Neonatal Electroencephalography Monitoring. J Clin Neurophysiol. 2019 Jan;36(1):9-13. doi: 10.1097/WNP.0000000000000525.

    PMID: 30289769RESULT

  • Sharpe C, Yang DZ, Haas RH, Reiner GE, Lee L, Capparelli EV; NEOLEV2 Investigators. Pharmacokinetic and pharmacodynamic data from the NEOLEV1 and NEOLEV2 studies. Arch Dis Child. 2024 Sep 25;109(10):854-860. doi: 10.1136/archdischild-2022-324952.

    PMID: 38902005DERIVED

MeSH Terms

Conditions

Seizures

Interventions

LevetiracetamPhenobarbital

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBarbituratesPyrimidinonesPyrimidines

Results Point of Contact

Title
Dr. Richard Haas
Organization
University of California San Diego, School of Medicine
rhaas@ucsd.edu
(858) 822-6700

Study Officials

  • Richard H Haas, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 22, 2012

First Posted

November 2, 2012

Study Start

March 1, 2013

Primary Completion

October 31, 2017

Study Completion

July 31, 2019

Last Updated

August 21, 2019

Results First Posted

August 21, 2019

Record last verified: 2019-08

Locations

US(1)