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Efficacy of Intravenous Levetiracetam in Neonatal Seizures

Information source: University of California, San Diego
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neonatal Seizures

Intervention: Intravenous levetiracetam (Drug); Intravenous phenobarbital (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Richard H. Haas

Official(s) and/or principal investigator(s):
Richard H Haas, MD, Principal Investigator, Affiliation: University of California, San Diego

Overall contact:
Richard H Haas, MD, Phone: 858-966-5819, Email: rhaas@ucsd.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To determine the efficacy of intravenous LEV in terminating neonatal seizures when given as first line therapy compared to phenobarbital

Secondary outcome:

To obtain dose escalation data by studying the additional efficacy of a further dose in non responders.

To evaluate the benefit of remote EEG monitoring

Evaluation of the accuracy of neonatal seizure detection algorithm

Detailed description: 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.

Eligibility

Minimum age: N/A. Maximum age: 14 Days. Gender(s): Both.

Criteria:

Inclusion Criteria: 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. Exclusion Criteria: 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.

Locations and Contacts

Richard H Haas, MD, Phone: 858-966-5819, Email: rhaas@ucsd.edu

University of California, San Diego Medical Center / Neonatal Intensive Care Unit (NICU), San Diego, California 92103, United States; Recruiting
Richard H Haas, MD, Phone: 858-822-6700, Email: rhaas@ucsd.edu
Gail E Reiner, DNP, FNP-C, Phone: 619-471-9134, Email: gereiner@ucsd.edu
Richard H Haas, MD, Principal Investigator
Additional Information

Related publications:

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.

Starting date: March 2013
Last updated: January 25, 2015

Page last updated: August 23, 2015

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