NCT00884052

Brief Summary

The hypothesis is that a loading dose of 20 mg/kg and a maintenance dose of 5 mg/kg of Levetiracetam is going to be safe and effective in the treatment of seizures in neonates.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
8.5 years until next milestone

Results Posted

Study results publicly available

March 26, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

3.9 years

First QC Date

April 17, 2009

Results QC Date

June 13, 2014

Last Update Submit

March 12, 2020

Conditions

SeizuresDisorder of Fetus or Newborn

Keywords

Neonatal seizures

Outcome Measures

Primary Outcomes (2)

  • Drug Clearance

    Day 1 and Day 7

  • Drug Half Life

    Day 1 and Day 7

Secondary Outcomes (1)

  • Levetiracetam Treated Number of Participants With Serious Adverse Events

    7 Days

Study Arms (1)

levetiracetam dose escalation

EXPERIMENTAL

6 Babies in Phase 1-Received Dose 1: 20 mg/kg; 5 mg/kg daily 12 Babies in Phase 2-Received Dose 2: 40 mg/kg; 10 mg/kg/day

Drug: Low dose levetiracetamDrug: High dose levetiracetam

Interventions

Low dose levetiracetamDRUG

20 mg/kg loading dose; 5 mg/kg daily for 7 days.

Also known as: Keppra
levetiracetam dose escalation
High dose levetiracetamDRUG

40 mg/kg IV load; 10 mg/kg/day maintenance

Also known as: Keppra
levetiracetam dose escalation

Eligibility Criteria

Age1 Minute - 14 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Newborns admitted to the UCSD, Children's Hospital or Sharp Mary Birch NICUs with seizures.
  • Term infants (gestational age greater than or equal to 37 weeks.
  • \> 2500 grams (max blood for study 6mL =3%).
  • Postnatal age 14 days or less.
  • Serum creatinine less than 1.2 at time of enrollment.
  • Received loading dose of phenobarbital 20mg/kg.
  • Are still experiencing either clinical or electroencephalographic seizures despite this therapy.
  • For whom parental consent to participate in the study is obtained.

You may not qualify if:

  • Biochemical abnormality - hypoglycemia, hypocalcemia-that when treated result in seizure cessation.
  • Severe hypoxic ischemic injury likely to result in imminent death
  • No rule-based criteria, (using lab or clinical parameters) adequately capture the complete nature of this clinical assessment.
  • In general any child receiving active treatment with head cooling will not be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego Medical Center / Neonatal Intensive Care Unit (NICU)

San Diego, California, 92103, United States

Location

Related Publications (1)

  • Sharpe CM, Capparelli EV, Mower A, Farrell MJ, Soldin SJ, Haas RH. A seven-day study of the pharmacokinetics of intravenous levetiracetam in neonates: marked changes in pharmacokinetics occur during the first week of life. Pediatr Res. 2012 Jul;72(1):43-9. doi: 10.1038/pr.2012.51. Epub 2012 Apr 11.

    PMID: 22495532RESULT

MeSH Terms

Conditions

SeizuresFetal Diseases

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Sponsor and Principal Investigator
Organization
University od California San Diego
rhaas@ucsd.edu
8588226700

Study Officials

  • Richard Haas, MD

    University of Calfornia, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 20, 2009

Study Start

April 1, 2007

Primary Completion

March 1, 2011

Study Completion

October 1, 2011

Last Updated

March 26, 2020

Results First Posted

March 26, 2020

Record last verified: 2020-03

Locations

US(1)