Dosing of Levetiracetam (Keppra) in Neonates

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT01239212
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Duration (Months): 10
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Seizures	Drug: levetiracetam	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic Profile [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 30 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Gestational age ≥ 32 weeks

• Postnatal age ≤ 30 days

• Birth weight ≥ 2000 grams

• Admitted to the Neonatal Intensive Care Unit at Cincinnati Children's Hospital

• Clinical or electrographic seizures of any etiology

• Seizures or seizure prophylaxis requiring treatment with levetiracetam

• Parental consent obtained

Exclusion Criteria:

• Infants with renal insufficiency indicated by serum creatinine > 2.0 at any time

• Infants who have previously received levetiracetam

• Parents refuse consent

• Attending physician does not wish the infant to be enrolled in the study

• Infants who are currently receiving an investigational drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• Children's Hospital Medical Center, Cincinnati

Investigators

• Principal Investigator: Stephanie Merhar, MD, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephanie Merhar, MD, Assistant Professor, Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT01239212
• Other Study ID Numbers: 101335
• First Posted: Nov 11, 2010
• Last Update Posted: Sep 5, 2021
• Last Verified: Aug 1, 2021

• Keywords provided by Stephanie Merhar, MD, Assistant Professor, Children's Hospital Medical Center, Cincinnati: seizures; neonate; levetiracetam; Epilepsy; central nervous system diseases; anticonvulsants
• Additional relevant MeSH terms: Seizures; Levetiracetam

Study Results

Participant Flow

Recruitment Details	Recruitment was from 9/2010 to 8/2011 from the NICU at Cincinnati Children's Hospital.

Arm/Group Title	Single Arm, 50 mg/kg of Levetiracetam
Arm/Group Description	Single arm, 50 mg/kg of levetiracetam
Period Title: Overall Study
STARTED	7
COMPLETED	7
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Single Arm, 50 mg/kg of Levetiracetam
Arm/Group Description	Single arm, 50 mg/kg of levetiracetam
Overall Participants	7
Age (Count of Participants)
<=18 years	7 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	3 42.9%
Male	4 57.1%
Region of Enrollment (participants) [Number]
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetic Profile
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)

Outcome Measure Data

Analysis Population Description

all participants had adequate levels drawn for analysis

Arm/Group Title	Single Arm, 50 mg/kg of Levetiracetam
Arm/Group Description	Single arm, 50 mg/kg of levetiracetam
Measure Participants	7
Median (Full Range) [ml/min/kg]	0.51 (0)

Adverse Events

Time Frame	24 hours after dose
Arm/Group Title	Single Arm, 50 mg/kg of Levetiracetam
Arm/Group Description	Single arm, 50 mg/kg of levetiracetam
All Cause Mortality
	Single Arm, 50 mg/kg of Levetiracetam
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Single Arm, 50 mg/kg of Levetiracetam
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	Single Arm, 50 mg/kg of Levetiracetam
	Affected / at Risk (%)	# Events
Total	0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.