MedTrace Logo

A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.

NCT00175890 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2020-10-01

No results posted yet for this study

Summary

To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Other neuropsychological clinical assessments will be performed during the 34 day length of the study.

Conditions

  • Epilepsy, Partial

Interventions

DRUG

Levetiracetam

Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d.

OTHER

Placebo

Placebo solution, which is indistinguishable from the Levetiracetam oral solution.

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · UCB Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2007-01-31
Completion
2007-01-31

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Poland
  • Romania
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00175890 on ClinicalTrials.gov