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Efficacy of Intravenous Levetiracetam in Neonatal Seizures

NCT01720667 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2019-08-21

Study results available
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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.

Conditions

  • Neonatal Seizures

Interventions

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.

Sponsors & Collaborators

  • University of California, San Diego

    collaborator OTHER

  • Rady Children's Hospital, San Diego

    collaborator OTHER

  • Auckland City Hospital

    collaborator OTHER_GOV

  • Sharp Mary Birch Hospital for Women & Newborns

    collaborator OTHER

  • UCSF Benioff Children's Hospital Oakland

    collaborator OTHER

  • Food and Drug Administration (FDA)

    collaborator FED

  • Richard H. Haas

    lead OTHER

Principal Investigators

  • Richard H Haas, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Minutes
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2017-10-31
Completion
2019-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01720667 on ClinicalTrials.gov