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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00884052




Registration number
NCT00884052
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
Scientific title
Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures
Secondary ID [1] 0 0
Thrasher 02825-1
Universal Trial Number (UTN)
Trial acronym
Keppra
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seizures 0 0
Disorder of Fetus or Newborn 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Low dose levetiracetam
Treatment: Drugs - High dose levetiracetam

Experimental: levetiracetam dose escalation - 6 Babies in Phase 1-Received Dose 1: 20 mg/kg; 5 mg/kg daily 12 Babies in Phase 2-Received Dose 2: 40 mg/kg; 10 mg/kg/day


Treatment: Drugs: Low dose levetiracetam
20 mg/kg loading dose; 5 mg/kg daily for 7 days.

Treatment: Drugs: High dose levetiracetam
40 mg/kg IV load; 10 mg/kg/day maintenance
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Drug Clearance
Timepoint [1] 0 0
Day 1 and Day 7
Primary outcome [2] 0 0
Drug Half Life
Timepoint [2] 0 0
Day 1 and Day 7
Secondary outcome [1] 0 0
Levetiracetam Treated Number of Participants With Serious Adverse Events
Timepoint [1] 0 0
7 Days

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.
Minimum age
1 Minute
Maximum age
14 Days
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California

Funding & Sponsors
Primary sponsor type
Other
Name
Richard H. Haas
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Thrasher Research Fund
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Haas, MD
Address 0 0
University of Calfornia, San Diego
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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

TypeCitations or Other Details
Journal Sharpe CM, Capparelli EV, Mower A, Farrell MJ, Sol... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00884052