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NCT01239212 · ClinicalTrials.gov registry record · Phase 1
Dosing of Levetiracetam (Keppra) in Neonates
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT01239212 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 7 participants.
The verdict
NCT01239212, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.
Interventions
- DRUG levetiracetam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01239212
The ClinicalTrials.gov registry entry for NCT01239212 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which levetiracetam is the first listed.
NCT01239212 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01239212 about?
NCT01239212 is a clinical study titled "Dosing of Levetiracetam (Keppra) in Neonates". The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in te...
What is the current status of trial NCT01239212?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2010-09. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01239212?
The interventions under investigation include: levetiracetam (DRUG).
Who is sponsoring clinical trial NCT01239212?
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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