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NCT01261416 · ClinicalTrials.gov registry record
Pharmacokinetics of Levetiracetam (Keppra) in Neonates
A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- 18
- Enrollment target
NCT01261416: Completed study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01261416 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01261416 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- 18 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the pharmacokinetic profile of a loading dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of levetiracetam in term and preterm infants with seizures.
Primary Outcome
Blood specimens for quantitation of levetiracetam and its metabolite L057 will be obtained from an indwelling vascular catheter not used for study drug infusion or by heel stick in three different sampling schedules: Group 1 (n=6): at times 2-15 minutes after the end of infusion, 1-2 hours, and 12 hours post start of infusion Group 2 (n=6): at times 2-15 minutes after the end of infusion, 2-4 hours, and 18 hours post start of infusion Group 3 (n=6): at times 2-15 minutes after the end of infusi
Interventions
- DRUG levetiracetam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-10 |
| Est. Completion | 2010-07 |
What the finished NCT01261416 record still lists
NCT01261416 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 18 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which levetiracetam is the first listed.
NCT01261416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01261416 about?
NCT01261416 is a clinical study titled "Pharmacokinetics of Levetiracetam (Keppra) in Neonates". The primary objective of this study is to determine the pharmacokinetic profile of a loading dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of levetiracetam in term and preter...
What is the current status of trial NCT01261416?
This trial is currently completed. The enrollment target is 18 participants. The study started on 2008-10. Estimated completion is 2010-07.
What interventions are being tested in trial NCT01261416?
The interventions under investigation include: levetiracetam (DRUG).
Who is sponsoring clinical trial NCT01261416?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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