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

February 27, 2015 updated by: UCB Pharma

A 19-week, Randomized, Double-blind, Multicenter, Placebo-controlled Safety Study to Evaluate the Cognitive and Neuropsychological Effects of Levetiracetam 20 - 60 mg/kg/Day, Divided in Twice Daily Dosing, as Adjunctive Treatment in Children 4 - 16 Years Old, Inclusive, With Refractory Partial Onset Seizures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Scarborough, Ontario, Canada
      • Thornhill, Ontario, Canada
      • Toronto, Ontario, Canada
  • South Africa
      • Bloemfontein, South Africa
      • Cape Town, South Africa
      • Capitol Park, South Africa
      • Johannesburg, South Africa
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • La Jolla, California, United States
      • Los Angeles, California, United States
    • Colorado
      • Denver, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Bradenton, Florida, United States
      • Gainesville, Florida, United States
      • Loxahatchee, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Tallahassee, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Augusta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • New Jersey
      • Voorhees, New Jersey, United States
    • New York
      • Buffalo, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Germantown, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
      • Galveston, Texas, United States
      • Houston, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • West Virginia
      • Morgantown, West Virginia, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric subjects (4 - 16 years old) diagnosed with refractory partial onset seizures for a minimum of six months prior to Visit 1 experiencing at least two partial onset seizures during the four weeks prior to Visit 1 will be enrolled
  • Subjects should be on a stable regimen of one or a maximum of two other antiepileptic drugs (AEDs) for at least 2 weeks prior to Visit 1
  • Subject must have an Intelligence Quotient (IQ) as assessed during Visit 1 of at least 70
  • Subject and parent/guardian should be fluent in English

Exclusion Criteria:

  • Subject must not have had previous treatment with levetiracetam unless, in the opinion of the investigator, the subject's previous treatment was inadequate in dose or duration to provide an accurate assessment of the therapy, or the effect of levetiracetam was confounded by concomitant medication
  • Subject is receiving benzodiazepines on a routine or chronic basic and is unable to discontinue use four weeks prior to Visit 1
  • Subject has seizures too close together to accurately count
  • Subject has a current psychiatric disorder other than mild to moderate attention deficit, behavior, or learning disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levetiracetam (LEV)
Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.
Drug: Levetiracetam
Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.
Other Names:
  • Keppra
Placebo Comparator: Matching Placebo (PBO)
Oral tablets and oral solution.
Other: Placebo (PB)
Oral tablets and oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Leiter International Performance Scale-Revised (Leiter-R) Attention and Memory (AM) Battery's Memory Screen Composite Score from Baseline (Visit 2) to the end of the Evaluation Period (Week 12 or Early Discontinuation Visit)
Time Frame: Baseline (Visit 2) to the end of the Evaluation Period (Week 12 or Early Discontinuation Visit)
The Leiter-R includes two groupings of sub-tests: (1) the Visualization and Reasoning (VR) Battery with 10 sub-tests of nonverbal intellectual ability related to visualization, reasoning, and spatial ability; and (2) the Attention and Memory (AM) Battery with 10 sub-tests of nonverbal attention and memory function. The Examiner Rating Scale has 49 items that describe the child's activity level, attention, impulse control, and other emotional characteristics that may interact with test performance. The focus of the items is on actions, verbalizations, moods and other behaviors of the child. The examiner rates the child using the following scale: 0 = rarely or never; 1 = sometimes; 2 = often; 3 = usually or always.
Baseline (Visit 2) to the end of the Evaluation Period (Week 12 or Early Discontinuation Visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Wide Range Assessment of Memory and Learning-Second Edition (WRAML-2) General Memory from Baseline to Week 12 or Early Discontinuation Visit (EDV)
Time Frame: Baseline to Week 12 or EDV
The WRAML-2 is comprised of 2 Verbal, 2 Visual, and 2 Attention-Concentration sub-tests, yielding a Verbal Memory Index, a Visual Memory Index and an Attention-Concentration Index. Together these sub-tests yield a General Memory Index. Scaled and standard scores allow performance comparisons based on age and 4 delayed recall sub-tests include guidelines for determining the level of recall. A composite General Memory Index score will be computed.
Baseline to Week 12 or EDV
Change from Baseline in Wide Range Assessment of Memory and Learning-Second Edition (WRAML-2) Visual Memory Index from Baseline to Week 12 or Early Discontinuation Visit (EDV)
Time Frame: Baseline to Week 12 or EDV
The WRAML-2 is comprised of 2 Verbal, 2 Visual, and 2 Attention-Concentration sub-tests, yielding a Verbal Memory Index, a Visual Memory Index and an Attention-Concentration Index. Together these sub-tests yield a General Memory Index. Scaled and standard scores allow performance comparisons based on age and 4 delayed recall sub-tests include guidelines for determining the level of recall. A composite General Memory Index score will be computed.
Baseline to Week 12 or EDV
Change from Baseline in Wide Range Assessment of Memory and Learning-Second Edition (WRAML-2) Verbal Memory Index from Baseline to Week 12 or Early Discontinuation Visit (EDV)
Time Frame: Baseline to Week 12 or EDV
The WRAML-2 is comprised of 2 Verbal, 2 Visual, and 2 Attention-Concentration sub-tests, yielding a Verbal Memory Index, a Visual Memory Index and an Attention-Concentration Index. Together these sub-tests yield a General Memory Index. Scaled and standard scores allow performance comparisons based on age and 4 delayed recall sub-tests include guidelines for determining the level of recall. A composite General Memory Index score will be computed.
Baseline to Week 12 or EDV
Change from Baseline in Wide Range Assessment of Memory and Learning-Second Edition (WRAML-2) Attention/Concentration Index from Baseline to Week 12 or Early Discontinuation Visit (EDV)
Time Frame: Baseline to Week 12 or EDV
The WRAML-2 is comprised of 2 Verbal, 2 Visual, and 2 Attention-Concentration sub-tests, yielding a Verbal Memory Index, a Visual Memory Index and an Attention-Concentration Index. Together these sub-tests yield a General Memory Index. Scaled and standard scores allow performance comparisons based on age and 4 delayed recall sub-tests include guidelines for determining the level of recall. A composite General Memory Index score will be computed.
Baseline to Week 12 or EDV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

March 3, 2005

First Submitted That Met QC Criteria

March 3, 2005

First Posted (Estimate)

March 4, 2005

Study Record Updates

Last Update Posted (Estimate)

March 2, 2015

Last Update Submitted That Met QC Criteria

February 27, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01103
  • 2014-004396-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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