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Epilepsy, PartialPhase 2NCT00105040

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

A Phase 2 study testing Levetiracetam in people with Epilepsy, Partial, run by UCB Pharma at 45 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 16 years
Conditions the study is for
Epilepsy, Partial
What is being tested?
Levetiracetam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
45 sitesin 3 countries
Study dates
Sep 2004to Mar 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

45 sites in 3 countries.

45 sites in 3 countries

United States38 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Birmingham, Alabama

  • Study site

    Bradenton, Florida

  • Study site

    Buffalo, New York

  • Study site

    Charleston, South Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cleveland, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Fort Worth, Texas

  • Study site

    Gainesville, Florida

  • Study site

    Galveston, Texas

  • Study site

    Germantown, Tennessee

  • Study site

    Hershey, Pennsylvania

  • Study site

    Houston, Texas

  • Study site

    La Jolla, California

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Loxahatchee Groves, Florida

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Morgantown, West Virginia

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Orlando, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Richmond, Virginia

  • Study site

    Rochester, New York

  • Study site

    Seattle, Washington

  • Study site

    Tallahassee, Florida

  • Study site

    Tampa, Florida

  • Study site

    Tucson, Arizona

  • Study site

    Voorhees Township, New Jersey

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

South Africa4 sites

  • Study site

    Bloemfontein

  • Study site

    Cape Town

  • Study site

    Capitol Park

  • Study site

    Johannesburg

Other trials in South Africa

Canada3 sites

  • Study site

    Scarborough Village, Ontario

  • Study site

    Thornhill, Ontario

  • Study site

    Toronto, Ontario

Other trials in Canada

About this study

Official title: 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.

Being tested
Levetiracetam, Placebo (PB)
Keywords
Partial onset seizures, epilepsy, levetiracetam, Keppra, cognition, behavior, pediatry
Medical subject headings
Epilepsies, Partial, Epilepsy, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevetiracetamDrug

    Also called Keppra

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

  • Placebo (PB)Other

    Oral tablets and oral solution

Study groups in NCT00105040
Study groupRoleWhat they receive
Levetiracetam (LEV)ExperimentalOral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.
Receives: Drug: Levetiracetam
Matching Placebo (PBO)Placebo comparatorOral tablets and oral solution.
Receives: Other: Placebo (PB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Visit 2) to the end of the Evaluation Period (Week 12 or Early Discontinuation Visit)

Secondary outcomes (4)

  1. 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)

    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.

    Measured: Baseline to Week 12 or EDV

  2. 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)

    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.

    Measured: Baseline to Week 12 or EDV

  3. 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)

    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.

    Measured: Baseline to Week 12 or EDV

  4. 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)

    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.

    Measured: Baseline to Week 12 or EDV

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2005 (estimated)
  2. Study startSep 2004
  3. Primary completionMar 2007
  4. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00105040
Sponsor's protocol ID
N01103
Other IDs
2014-004396-23, 2014
Status last verified
Feb 2015
First submitted
3 Mar 2005
Last updated
2 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19702752

  • 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.

    PubMed 20547106

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Levetiracetam in people with Epilepsy, Partial, run by UCB Pharma at 45 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, South Africa, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00105040, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.

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