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Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam (LEV) | Experimental | LEV dose was titrated to a level of 60 mg/kg/day. The initial dose level was 20 mg/kg/day for the first two weeks, followed by a dose level of 40 mg/kg/day for two weeks. If lower doses were well tolerated, the LEV dose was increased to a dose level of 60 mg/kg/day for the remaining 10 weeks. The dose level could be reduced to 40 mg/kg/day if the patient did not tolerate LEV at a dose level of 60 mg/kg/day. |
|
| Placebo | Placebo Comparator | Subjects received Placebo matching to LEV treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Partial onset seizure frequency (Type I, Type IC included) per week during the Treatment period | Calculated as 7-day partial onset seizure frequency. | During the 14-weeks Treatment period (Week 8 to Week 22) |
| Measure | Description | Time Frame |
|---|---|---|
| 50% responder rate in seizure frequency per week during the Treatment Period | Response rate is defined as percent of patients experiencing at least a 50% reduction from baseline in the seizure frequency per week during the Treatment Period. | During the 14-weeks Treatment period (Week 8 to Week 22) |
| Percent of patients with categorized reduction from baseline in seizure frequency per week during the Treatment Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 844 599 2273 (UCB) | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16641323 | Background | Glauser TA, Ayala R, Elterman RD, Mitchell WG, Van Orman CB, Gauer LJ, Lu Z; N159 Study Group. Double-blind placebo-controlled trial of adjunctive levetiracetam in pediatric partial seizures. Neurology. 2006 Jun 13;66(11):1654-60. doi: 10.1212/01.wnl.0000217916.00225.3a. Epub 2006 Apr 26. | |
| 17057745 | Background |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| 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 |
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|
| Placebo | Drug | Placebo tablets for oral administration that were identical in appearance to the respective formulations (LTTW and HTTW) were used as reference therapy |
|
Categories as follows: <-25%, -25% to <25%, 25% to <50%, 50% to <75%, 75% to <100%, and 100% |
| From Baseline to the 14-weeks Treatment period |
| Change from baseline in the average duration of seizure free intervals | Intervals are defined as seizure-free if no seizures are reported. | From Baseline to the 14-weeks Treatment period |
| Number of seizure free days during the Treatment Period | A day is regarded as seizure-free if no seizures are reported. | During the 14-weeks Treatment period (Week 8 to Week 22) |
| Absolute change from baseline in partial onset seizure frequency per week during the Treatment Period | Absolute change from baseline in partial onset seizure frequency during the Treatment Period standardized to 1 week period. A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline. | Baseline, During the 14-weeks Treatment period (Week 8 to Week 22) |
| Absolute change from baseline in partial onset seizure frequency per week during the Titration Period | Absolute change from baseline in partial onset seizure frequency during the Titration Period standardized to 1 week period. A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline. | Baseline, During the 6-weeks Titration period (Week 8 to Week 14) |
| Absolute change from baseline in partial onset seizure frequency per week during the Evaluation Period | Absolute change from baseline in partial onset seizure frequency during the Evaluation Period standardized to 1 week period. A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline. | Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22) |
| Percent change from baseline in partial onset seizure frequency per week during the Treatment Period | Percent change from baseline in partial onset seizure frequency during the Treatment Period standardized to 1 week period. A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline. | Baseline, During the 14-weeks Treatment period (Week 8 to Week 22) |
| Percent change from baseline in partial onset seizure frequency per week during the Titration Period | Percent change from baseline in partial onset seizure frequency during the Titration Period standardized to 1 week period. A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline. | Baseline, During the 6-weeks Titration period (Week 8 to Week 14) |
| Percent change from baseline in partial onset seizure frequency per week during the Evaluation Period | Percent change from baseline in partial onset seizure frequency during the Evaluation Period standardized to 1 week period. A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline. | Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22) |
| Cumulative percentage of patients who were seizure-free since the beginning of the Evaluation Period | A subject was regarded as seizure-free if not seizures were reported since the beginning of the Evaluation Period. | Beginning of the Evaluation Period (Week 14) |
| Partial onset seizure frequency per week during the Titration Period | Calculated as 7-day partial onset seizure frequency. | During the 6-weeks Titration period (Week 8 to Week 14) |
| Partial onset seizure frequency per week during the Evaluation Period | Calculated as 7-day partial onset seizure frequency. | During the 6-weeks Evaluation period (Week 8 to Week 14) |
| Total seizure frequency per week (Types I + II + III) during the Treatment Period | Calculated as 7-day partial onset seizure frequency. | During the 14-weeks Treatment period (Week 8 to Week 22) |
| Total seizure frequency per week (Types I + II + III) during the Titration Period | Calculated as 7-day partial onset seizure frequency. | During the 6-weeks Titration period (Week 8 to Week 14) |
| Total seizure frequency per week (Types I + II + III) during the Evaluation Period | Calculated as 7-day partial onset seizure frequency. | During the 6-weeks Evaluation period (Week 8 to Week 14) |
| Jensen FE, Bourgeois BF. Randomized trial supports use of levetiracetam adjunctive therapy to treat partial seizures in children. Nat Clin Pract Neurol. 2006 Nov;2(11):596-7. doi: 10.1038/ncpneuro0325. No abstract available. |
| 34033237 | Derived | Johnson ME, McClung C, Bozorg AM. Analyses of seizure responses supportive of a novel trial design to assess efficacy of antiepileptic drugs in infants and young children with epilepsy: Post hoc analyses of pediatric levetiracetam and lacosamide trials. Epilepsia Open. 2021 Jun;6(2):359-368. doi: 10.1002/epi4.12482. Epub 2021 May 3. |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |