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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
Sponsor:
Information provided by (Responsible Party):
Stephanie Merhar, MD, Children's Hospital Medical Center, Cincinnati

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Seizures
Intervention Drug: levetiracetam
Enrollment 7
Recruitment Details Recruitment was from 9/2010 to 8/2011 from the NICU at Cincinnati Children's Hospital.
Pre-assignment Details  
Arm/Group Title Single Arm, 50 mg/kg of Levetiracetam
Hide Arm/Group Description Single arm, 50 mg/kg of levetiracetam
Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Single Arm, 50 mg/kg of Levetiracetam
Hide Arm/Group Description Single arm, 50 mg/kg of levetiracetam
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
7
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
3
  42.9%
Male
4
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Pharmacokinetic Profile
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
all participants had adequate levels drawn for analysis
Arm/Group Title Single Arm, 50 mg/kg of Levetiracetam
Hide Arm/Group Description:
Single arm, 50 mg/kg of levetiracetam
Overall Number of Participants Analyzed 7
Median (Full Range)
Unit of Measure: ml/min/kg
0.51
(0.42 to 0.62)
2.Secondary Outcome
Title Change in Vital Sign Baseline
Hide Description Short term treatment-emergent adverse effects of levetiracetam will be measured by change from vital sign baseline in the 24 hours after the dose.
Time Frame 24 hours after loading dose
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose.
Time Frame 24 hours after dose
Outcome Measure Data Not Reported
Time Frame 24 hours after dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm, 50 mg/kg of Levetiracetam
Hide Arm/Group Description Single arm, 50 mg/kg of levetiracetam
All-Cause Mortality
Single Arm, 50 mg/kg of Levetiracetam
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm, 50 mg/kg of Levetiracetam
Affected / at Risk (%)
Total   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm, 50 mg/kg of Levetiracetam
Affected / at Risk (%)
Total   0/7 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Stephanie Merhar
Organization: Cincinnati Children's Hospital Medical Center
Phone: 513-636-4200
EMail: stephanie.merhar@cchmc.org
Layout table for additonal information
Responsible Party: Stephanie Merhar, MD, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01239212     History of Changes
Other Study ID Numbers: 101335
First Submitted: October 28, 2010
First Posted: November 11, 2010
Results First Submitted: February 26, 2014
Results First Posted: September 8, 2014
Last Update Posted: August 7, 2015