Summary

at San Diego, California
study started
estimated completion:
Richard H Haas

Description

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.

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

Details

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 2 randomized blinded controlled study.

Keywords

Neonatal Seizures Seizures Neonates Anticonvulsants Treatment Levetiracetam Phenobarbital Etiracetam Piracetam Intravenous levetiracetam Intravenous phenobarbital

Eligibility

You can join if…

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

You CAN'T join if...

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

Location

  • University of California, San Diego Medical Center / Neonatal Intensive Care Unit (NICU)
    San Diego California 92103 United States

Lead Scientist

  • Richard H Haas
    Professor, Neurosciences. Authored (or co-authored) 34 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Richard H. Haas
ID
NCT01720667
Phase
Phase 1/2
Study Type
Interventional
Last Updated