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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004396-23 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam (LEV) | Experimental | Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing. |
|
| Matching Placebo (PBO) | Placebo Comparator | Oral tablets and oral solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing. |
|
| 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) | 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) |
| 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) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19702752 | Result | 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. | |
| 20547106 |
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| Placebo (PB) | Other | Oral tablets and oral solution |
|
| 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) | 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) | 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) | 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 |
| Phoenix |
| Arizona |
| United States |
| Tucson | Arizona | United States |
| Little Rock | Arkansas | United States |
| La Jolla | California | United States |
| Los Angeles | California | United States |
| Denver | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Bradenton | Florida | United States |
| Gainesville | Florida | United States |
| Loxahatchee Groves | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Tallahassee | Florida | United States |
| Tampa | Florida | United States |
| Atlanta | Georgia | United States |
| Augusta | Georgia | United States |
| Chicago | Illinois | United States |
| Voorhees Township | New Jersey | United States |
| Buffalo | New York | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Winston-Salem | North Carolina | United States |
| Cleveland | Ohio | United States |
| Hershey | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Germantown | Tennessee | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Galveston | Texas | United States |
| Houston | Texas | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | United States |
| Morgantown | West Virginia | United States |
| Milwaukee | Wisconsin | United States |
| Scarborough Village | Ontario | Canada |
| Thornhill | Ontario | Canada |
| Toronto | Ontario | Canada |
| Bloemfontein | South Africa |
| Cape Town | South Africa |
| Capitol Park | South Africa |
| Johannesburg | South Africa |
| 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. |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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