Trial record 1 of 2 for:
NCT00105040
A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures
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| ClinicalTrials.gov Identifier: NCT00105040 |
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Recruitment Status :
Completed
First Posted : March 4, 2005
Last Update Posted : March 2, 2015
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Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy, Partial | Drug: Levetiracetam Other: Placebo (PB) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 87 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | September 2004 |
| Actual Primary Completion Date : | March 2007 |
| Actual Study Completion Date : | March 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Pyridoxal 5'-phosphate-dependent epilepsy
Autosomal dominant partial epilepsy with auditory features
MedlinePlus related topics:
Seizures
Drug Information available for:
Levetiracetam
| Arm | Intervention/treatment |
|---|---|
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Experimental: Levetiracetam (LEV)
Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.
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Drug: Levetiracetam
Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.
Other Name: Keppra |
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Placebo Comparator: Matching Placebo (PBO)
Oral tablets and oral solution.
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Other: Placebo (PB)
Oral tablets and oral solution |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
- 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.
- 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.
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 4 Years to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105040
Locations
| United States, Alabama | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| Phoenix, Arizona, United States | |
| Tucson, Arizona, United States | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| La Jolla, California, United States | |
| Los Angeles, California, United States | |
| United States, Colorado | |
| Denver, Colorado, United States | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States | |
| 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 | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| Augusta, Georgia, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| United States, New Jersey | |
| Voorhees, New Jersey, United States | |
| United States, New York | |
| Buffalo, New York, United States | |
| New York, New York, United States | |
| Rochester, New York, United States | |
| United States, North Carolina | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| Cleveland, Ohio, United States | |
| United States, Pennsylvania | |
| Hershey, Pennsylvania, United States | |
| Philadelphia, Pennsylvania, United States | |
| Pittsburgh, Pennsylvania, United States | |
| United States, South Carolina | |
| Charleston, South Carolina, United States | |
| United States, Tennessee | |
| Germantown, Tennessee, United States | |
| United States, Texas | |
| Dallas, Texas, United States | |
| Fort Worth, Texas, United States | |
| Galveston, Texas, United States | |
| Houston, Texas, United States | |
| United States, Virginia | |
| Norfolk, Virginia, United States | |
| Richmond, Virginia, United States | |
| United States, Washington | |
| Seattle, Washington, United States | |
| United States, West Virginia | |
| Morgantown, West Virginia, United States | |
| United States, Wisconsin | |
| Milwaukee, Wisconsin, United States | |
| 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 | |
Sponsors and Collaborators
UCB Pharma
Investigators
| Study Director: | UCB Clinical Trial Call Center | UCB Pharma |
Publications of Results:
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT00105040 |
| Other Study ID Numbers: |
N01103 2014-004396-23 ( EudraCT Number ) |
| First Posted: | March 4, 2005 Key Record Dates |
| Last Update Posted: | March 2, 2015 |
| Last Verified: | February 2015 |
Keywords provided by UCB Pharma:
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Partial onset seizures epilepsy levetiracetam Keppra |
cognition behavior pediatry |
Additional relevant MeSH terms:
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Epilepsy Seizures Epilepsies, Partial Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Levetiracetam Anticonvulsants Nootropic Agents |