Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures - Full Text View

Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures (Keppra)

This study is currently recruiting participants.

Verified by University of California, San Diego, April 2009

First Received: April 17, 2009 No Changes Posted

Sponsored by:	University of California, San Diego
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00884052

Purpose

The hypothesis is that a loading dose of 20 mg/kg and a maintenance dose of 5 mg/kg of Levetiracetam is going to be safe and effective in the treatment of seizures in neonates.

Condition	Intervention	Phase
Seizures Neonates	Drug: Levetiracetam	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Seizures

Drug Information available for: Levetiracetam

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

Pharmacokinetic profile [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	April 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

20 mg/kg loading dose; 5 mg/kg daily for 7 days.

Eligibility

Ages Eligible for Study:	up to 14 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newborns admitted to the UCSD, Children's Hospital or Sharp Mary Birch NICUs with seizures.
Term infants (gestational age greater than or equal to 37 weeks.
> 2500 grams (max blood for study 6mL =3%).
Postnatal age < 14 days.
Serum creatinine less than 1.2 at time of enrollment.
Received loading dose of phenobarbital 20mg/kg.
Are still experiencing either clinical or electroencephalographic seizures despite this therapy.
For whom parental consent to participate in the study is obtained.

Exclusion Criteria:

Biochemical abnormality - hypoglycemia, hypocalcemia-that when treated result in seizure cessation.
Severe hypoxic ischemic injury likely to result in imminent death
The only significant exclusions that will be made in recruitment and enrollment will be the exclusion of infants who are judged by the attending neonatologist to be so critically ill that death is imminent and benefit from neonatal intensive care is very unlikely.
No rule-based criteria, (using lab or clinical parameters) adequately capture the complete nature of this clinical assessment.
In general any child receiving active treatment with head cooling will not be excluded.
Mechanical ventilation and/or the use of inotropic agents to support blood pressure will not be exclusion criteria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884052

Contacts

Contact: Richard Haas, MD	858-822-6705	rhaas@ucsd.edu
Contact: Michael J. Farrell, RN	858-246-0011	mjfarrell@ucsd.edu

Locations

United States, California
University of California, San Diego Medical Center / NICU	Recruiting
San Diego, California, United States, 92103
Contact: Richard Haas, MD 858-822-6705 rhaas@ucsd.edu
Contact: Michael J Farrell, RN 858-246-0011 mjfarrell@ucsd.edu
Principal Investigator: Richard Haas, MD

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator:

Richard Haas, MD

University of Calfornia, San Diego

More Information

No publications provided

Responsible Party:	University of California, San Diego ( Richard Haas, MD )
Study ID Numbers:	Thrasher 02825-1
Study First Received:	April 17, 2009
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00884052 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

Neonatal seizures

Study placed in the following topic categories:

Nootropic Agents
Signs and Symptoms
Epilepsy
Seizures
Neurologic Manifestations

Central Nervous System Diseases
Etiracetam
Brain Diseases
Anticonvulsants

Additional relevant MeSH terms:

Nootropic Agents
Seizures
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Pharmacologic Actions
Signs and Symptoms

Epilepsy
Therapeutic Uses
Neurologic Manifestations
Etiracetam
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on August 24, 2009