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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00461409
Registration number
NCT00461409
Ethics application status
Date submitted
17/04/2009
Date registered
20/04/2009
Date last updated
26/03/2020
Titles & IDs
Public title
Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures
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Scientific title
Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures
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Secondary ID [1]
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Thrasher 02825-1
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Universal Trial Number (UTN)
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Trial acronym
Keppra
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key 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 or less.
* 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.
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Minimum age
1
Minute
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Maximum age
14
Days
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2011
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Sample size
Target
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Accrual to date
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Final
18
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Other
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Name
Richard H. Haas
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00461409
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Richard Haas, MD
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Address
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University of Calfornia, San Diego
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00461409
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