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A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures

NCT00105040 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2015-03-02

No results posted yet for this study

Summary

A 12-week Evaluation Period will be used to characterize potential cognitive and neuropsychological effects of LEV (20 - 60 mg/kg/day), as adjunctive treatment in children 4 - 16 years old, inclusive, with refractory partial onset seizures when compared to adjunctive treatment with placebo.

Conditions

  • Epilepsy, Partial

Interventions

DRUG

Levetiracetam

Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.

OTHER

Placebo (PB)

Oral tablets and oral solution

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · UCB Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • United States
  • Canada
  • South Africa

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 NCT00105040 on ClinicalTrials.gov