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
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