Phase 2
N=18
Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures
Seizures · Disorder of Fetus or Newborn
Bottom Line
View on ClinicalTrials.gov: NCT00884052 ↗Enrolled (actual)
18
Serious AEs
5.6%
Results posted
Mar 2020
Primary outcome: Primary: Drug Clearance — 0.71; 1.31 ml/min/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Low dose levetiracetam (Drug); High dose levetiracetam (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Richard H. Haas
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug Clearance |
0.71; 1.31 | — |
| PRIMARY Drug Half Life |
18.5; 9.1 | — |
| SECONDARY Levetiracetam Treated Number of Participants With Serious Adverse Events |
0; 1 | — |
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.
Eligibility 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 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.
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.
Data sourced from ClinicalTrials.gov (NCT00884052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.