Dosing of Levetiracetam (Keppra) in Neonates
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|ClinicalTrials.gov Identifier: NCT01239212|
Recruitment Status : Completed
First Posted : November 11, 2010
Results First Posted : September 8, 2014
Last Update Posted : August 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Seizures||Drug: levetiracetam||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
- Drug: levetiracetam
50 mg/kg single loading dose of IV levetiracetam
- Pharmacokinetic Profile [ Time Frame: 5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses) ]3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm.
- Change in Vital Sign Baseline [ Time Frame: 24 hours after loading dose ]Short term treatment-emergent adverse effects of levetiracetam will be measured by change from vital sign baseline in the 24 hours after the dose.
- Number of Participants With Adverse Events [ Time Frame: 24 hours after dose ]Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239212
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Stephanie Merhar, MD||Children's Hospital Medical Center, Cincinnati|