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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-000199-14 | EudraCT Number |
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To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Other neuropsychological clinical assessments will be performed during the 34 day length of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days. |
|
| Levetiractem | Experimental | 10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d. |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate for total partial onset seizures as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline) | Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for partial onset seizures divided by the total number of subjects. If a subject had < 24 hours of usable Evaluation video-EEG time (including zero time available) and withdrawal from the study with reasons linked to lack or loss of efficacy, the subject was counted as a non-responder. | 48-hours in Evaluation Period and 48-hours in Selection Period |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate for total seizures (all types) as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline) | Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for all seizure types divided by the total number of subjects. Subjects who withdrew or dropped out before the first 24 hours Evaluation video-EEG with reasons linked to lack of efficacy were considered as non-responders. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic). |
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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 |
|---|---|---|---|
| 19243423 | Result | Pina-Garza JE, Nordli DR Jr, Rating D, Yang H, Schiemann-Delgado J, Duncan B; Levetiracetam N01009 Study Group. Adjunctive levetiracetam in infants and young children with refractory partial-onset seizures. Epilepsia. 2009 May;50(5):1141-9. doi: 10.1111/j.1528-1167.2008.01981.x. Epub 2009 Feb 21. | |
| 21095488 | Derived |
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|
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| Placebo | Other | Placebo solution, which is indistinguishable from the Levetiracetam oral solution. |
|
| 48-hours in Evaluation Period and 48-hours in Selection Period |
| Percent reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG | A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. | 48-hours in Evaluation Period and 48-hours in Selection Period |
| Percent reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG | A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic). | 48-hours in Evaluation Period and 48-hours in Selection Period |
| Absolute reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG | A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement. | 48-hours in Evaluation Period and 48-hours in Selection Period |
| Absolute reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG | A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic). | 48-hours in Evaluation Period and 48-hours in Selection Period |
| Percent reduction in Average Daily Frequency (ADF) of electro-clinical partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG for children 1 month to less than 6 months old | A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. For children 1 month to less than 6 months old, partial onset seizure counts were based on electroclinical seizures plus electrographic seizures. | 48-hours in Evaluation Period and 48-hours in Selection Period |
| Percentage of drop-outs for any reasons during the study | During the study (up to 20 days) |
| Percentage of drop-outs due to lack of efficacy during the study | During the study (up to 20 days) |
| Percentage of drop-outs before 24 hours of Evaluation video-EEG for reasons other than lack or loss of efficacy | During the study (up to 20 days) |
| Time to Exit (TTE) during the Evaluation Period | For early termination subjects in the Evaluation period the TTE is the time to discontinuing the study for any reason. TTE was defined as the day of study discontinuation - the day of randomization + 1. For completed subjects, the TTE was censored on Day 6. | During Evaluation Period (Day 1 to Day 6) |
| Mobile |
| Alabama |
| United States |
| Tucson | Arizona | United States |
| Little Rock | Arkansas | United States |
| Los Angeles | California | United States |
| Gainesville | Florida | United States |
| Loxahatchee Groves | Florida | United States |
| Miami | Florida | United States |
| Tallahassee | Florida | United States |
| Tampa | Florida | United States |
| Augusta | Georgia | United States |
| Boise | Idaho | United States |
| Chicago | Illinois | United States |
| New Orleans | Louisiana | United States |
| Boston | Massachusetts | United States |
| Detroit | Michigan | United States |
| Saint Paul | Minnesota | United States |
| Lebanon | New Hampshire | United States |
| Cherry Hill | New Jersey | United States |
| Edison | New Jersey | United States |
| Buffalo | New York | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Syracuse | New York | United States |
| Chapel Hill | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Portland | Oregon | United States |
| Danville | Pennsylvania | United States |
| Hershey | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Spartanburg | South Carolina | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Salt Lake City | Utah | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | United States |
| Morgantown | West Virginia | United States |
| Milwaukee | Wisconsin | United States |
| Buenos Aires | Argentina |
| Mendoza | Argentina |
| Pilar Buenos Aires | Argentina |
| Brussels | Belgium |
| Leuven | Belgium |
| Campinas | Brazil |
| Curitiba | Brazil |
| Porto Alegre | Brazil |
| Ribeirão Preto | Brazil |
| Rio de Janeiro | Brazil |
| São Paulo | Brazil |
| Vancouver | British Columbia | Canada |
| Winnepeg | Manitoba | Canada |
| St. John's | Newfoundland and Labrador | Canada |
| London | Ontario | Canada |
| Scarborough Village | Ontario | Canada |
| Saskatoon | Saskatchewan | Canada |
| Brno | Czechia |
| Prague | Czechia |
| Lille | France |
| Paris | France |
| Rouen | France |
| Strasbourg | France |
| Kehl | Kork | Germany |
| Berlin | Germany |
| Erlangen | Germany |
| Heidelberg | Germany |
| Jena | Germany |
| Kiel | Germany |
| Budapest | Hungary |
| Calambrone | Italy |
| Genoa | Italy |
| Milan | Italy |
| Roma | Italy |
| Mexico City | Mexico |
| Gdansk | Poland |
| Bucharest | Romania |
| Cluj-Napoca | Romania |
| Târgu Mureş | Romania |
| Kalingrad | Russia |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Glasgow | United Kingdom |
| London | United Kingdom |
| Pina-Garza JE, Schiemann-Delgado J, Yang H, Duncan B, Hadac J, Hunter SJ. Adjunctive levetiracetam in patients aged 1 month to <4 years with partial-onset seizures: subpopulation analysis of a prospective, open-label extension study of up to 48 weeks. Clin Ther. 2010 Oct;32(11):1935-50. doi: 10.1016/j.clinthera.2010.09.017. |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| 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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