Trial Outcomes & Findings for Dosing of Levetiracetam (Keppra) in Neonates (NCT NCT01239212)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

7 participants

Primary outcome timeframe

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)

Results posted on

2021-09-05

Participant Flow

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

Participant milestones

Participant milestones
Measure	Single Arm, 50 mg/kg of Levetiracetam Single arm, 50 mg/kg of levetiracetam
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dosing of Levetiracetam (Keppra) in Neonates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm, 50 mg/kg of Levetiracetam n=7 Participants Single arm, 50 mg/kg of levetiracetam
Age, Categorical <=18 years	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Population: all participants had adequate levels drawn for analysis

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.

Outcome measures

Outcome measures
Measure	Single Arm, 50 mg/kg of Levetiracetam n=7 Participants Single arm, 50 mg/kg of levetiracetam
Pharmacokinetic Profile	0.51 ml/min/kg Full Range 0 • Interval 0.42 to 0.62

Adverse Events

Single Arm, 50 mg/kg of Levetiracetam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stephanie Merhar

Cincinnati Children's Hospital Medical Center

Phone: 513-636-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place