Trial Outcomes & Findings for Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures (NCT NCT00884052)

NCT ID: NCT00884052

Last Updated: 2020-03-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: Day 1 and Day 7
• Results posted on: 2020-03-26

Participant Flow

Recruitment over 2 years from neonatal intensive care units

Participant milestones

Measure	Levetiracetam Low Dose Levetiracetam 20 mg/kg load followed by 5 mg/kg/day for 7 days. n=6	Levetiracetam High Dose Levetiracetam 40 mg/kg load followed by 10 mg/kg/day for 7 days. n=12
Overall Study STARTED	6	12
Overall Study COMPLETED	6	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures

Baseline characteristics by cohort

Measure	Levetiracetam Dose Escalation n=18 Participants Escalation of dose after 6 patients treated to 40 mg/kg IV load and 10mg/kg/day maintenance levetiracetam : 20 mg/kg loading dose; 5 mg/kg daily for 7 days. levetiracetam : 40 mg/kg IV load; 10 mg/kg/day maintenance
Age, Categorical <=18 years	18 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
Age, Continuous	2.44 Days STANDARD_DEVIATION 1.38 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
Region of Enrollment New Zealand	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 and Day 7

Population: Subjects were grouped together to improve the reliability of the analysis. The publication of these results reported a grouped analysis because of the small number of subjects in the low dose group, The groups were not analyzed individually.

Outcome measures

Measure	All Participants n=18 Participants Participants in both low dose and high dose arms are reported together	Levetiracetam High Dose 12 Babies in Phase 2-Received Dose 2: 40 mg/kg; 10 mg/kg/day
Drug Clearance Day 1	0.71 ml/min/kg Standard Deviation 0.27	—
Drug Clearance Day 7	1.31 ml/min/kg Standard Deviation 0.35	—

PRIMARY outcome

Timeframe: Day 1 and Day 7

Population: Subjects were grouped together to improve the reliability of the analysis. The publication of these results reported a grouped analysis because of the small number of subjects in the low dose group, The groups were not analyzed individually.

Outcome measures

Measure	All Participants n=18 Participants Participants in both low dose and high dose arms are reported together	Levetiracetam High Dose 12 Babies in Phase 2-Received Dose 2: 40 mg/kg; 10 mg/kg/day
Drug Half Life Day 1	18.5 hr Standard Deviation 7.1	—
Drug Half Life Day 7	9.1 hr Standard Deviation 2.0	—

SECONDARY outcome

Timeframe: 7 Days

Outcome measures

Measure	All Participants n=6 Participants Participants in both low dose and high dose arms are reported together	Levetiracetam High Dose n=12 Participants 12 Babies in Phase 2-Received Dose 2: 40 mg/kg; 10 mg/kg/day
Levetiracetam Treated Number of Participants With Serious Adverse Events	0 Participants	1 Participants

Adverse Events

All Participants

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants n=18 participants at risk There were two arms (1) Levetiracetam 20 mg/kg load followed by 5 mg/kg/day for 7 days. n=6 and (2) Levetiracetam 40 mg/kg load followed by 10 mg/kg/day for 7 days. n=12, however the data collected regarding adverse events was not recorded according to group, so all participants are reported together.
Nervous system disorders Respiratory failure	5.6% 1/18 • Number of events 1 • 7 days Mild adverse events which resolved spontaneously and were possibly related to treatment with LEV included mild sedation in 2 subjects, feeding difficulty in 3 subjects, mild apnea and bradycardia in one subject and decreased urine output responding to furosemide in one subject. In no case was LEV thought causative of an adverse event.

Other adverse events

Measure	All Participants n=18 participants at risk There were two arms (1) Levetiracetam 20 mg/kg load followed by 5 mg/kg/day for 7 days. n=6 and (2) Levetiracetam 40 mg/kg load followed by 10 mg/kg/day for 7 days. n=12, however the data collected regarding adverse events was not recorded according to group, so all participants are reported together.
Nervous system disorders Sedation	11.1% 2/18 • Number of events 2 • 7 days Mild adverse events which resolved spontaneously and were possibly related to treatment with LEV included mild sedation in 2 subjects, feeding difficulty in 3 subjects, mild apnea and bradycardia in one subject and decreased urine output responding to furosemide in one subject. In no case was LEV thought causative of an adverse event.
General disorders Feeding Difficulty	16.7% 3/18 • Number of events 3 • 7 days Mild adverse events which resolved spontaneously and were possibly related to treatment with LEV included mild sedation in 2 subjects, feeding difficulty in 3 subjects, mild apnea and bradycardia in one subject and decreased urine output responding to furosemide in one subject. In no case was LEV thought causative of an adverse event.
Nervous system disorders Apnea and Bradycardia	5.6% 1/18 • Number of events 1 • 7 days Mild adverse events which resolved spontaneously and were possibly related to treatment with LEV included mild sedation in 2 subjects, feeding difficulty in 3 subjects, mild apnea and bradycardia in one subject and decreased urine output responding to furosemide in one subject. In no case was LEV thought causative of an adverse event.
Renal and urinary disorders Decreased Urine output	5.6% 1/18 • Number of events 1 • 7 days Mild adverse events which resolved spontaneously and were possibly related to treatment with LEV included mild sedation in 2 subjects, feeding difficulty in 3 subjects, mild apnea and bradycardia in one subject and decreased urine output responding to furosemide in one subject. In no case was LEV thought causative of an adverse event.

Additional Information

Sponsor and Principal Investigator

University od California San Diego

Phone: 8588226700

Email: rhaas@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place