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

NCT00105040 | Completed Phase 2

• 2 other identifiers: N011032014-004396-23
• Study Type: interventional
• Target: 87
• Locations: 3 countries
• Sites: 45

Brief 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

Keywords

Partial onset seizures; epilepsy; levetiracetam; Keppra; cognition; behavior; pediatry

Outcome Measures

Primary Outcomes (1)

• 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)

  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 Outcomes (4)

• 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)

  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)

  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)

  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)

  Baseline to Week 12 or EDV

Study Arms (2)

Levetiracetam (LEV)

EXPERIMENTAL

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

Drug: Levetiracetam

Matching Placebo (PBO)

PLACEBO COMPARATOR

Oral tablets and oral solution.

Other: Placebo (PB)

Interventions

Levetiracetam DRUG

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

Also known as: Keppra

Levetiracetam (LEV)

Placebo (PB) OTHER

Oral tablets and oral solution

Matching Placebo (PBO)

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (45)

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Bradenton, Florida, United States

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Gainesville, Florida, United States

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Loxahatchee Groves, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Voorhees Township, New Jersey, United States

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Buffalo, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Germantown, Tennessee, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Scarborough Village, Ontario, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Bloemfontein, South Africa

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Cape Town, South Africa

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Capitol Park, South Africa

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Johannesburg, South Africa

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Related Publications (2)

• Levisohn PM, Mintz M, Hunter SJ, Yang H, Jones J; N01103 Levetiracetam Study Group. Neurocognitive effects of adjunctive levetiracetam in children with partial-onset seizures: a randomized, double-blind, placebo-controlled, noninferiority trial. Epilepsia. 2009 Nov;50(11):2377-89. doi: 10.1111/j.1528-1167.2009.02197.x. Epub 2009 Aug 21.

  PMID: 19702752 RESULT

• de la Loge C, Hunter SJ, Schiemann J, Yang H. Assessment of behavioral and emotional functioning using standardized instruments in children and adolescents with partial-onset seizures treated with adjunctive levetiracetam in a randomized, placebo-controlled trial. Epilepsy Behav. 2010 Jul;18(3):291-8. doi: 10.1016/j.yebeh.2010.04.017. Epub 2010 May 23.

  PMID: 20547106 RESULT

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy; Behavior

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• UCB Clinical Trial Call Center

  UCB Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: September 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: March 2, 2015

Record last verified: 2015-02

Locations

CA (3); US (38); ZA (4)