Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures
- Registration Number
- NCT00615615
- Lead Sponsor
- UCB Pharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
- diagnosis of epilepsy with uncontrolled partial onset seizures, whether or not secondarily generalized, and the diagnosis was >= 6 months before the Selection Visit
- epilepsy was classifiable according to the ILAE Classification
- >= 4 partial onset seizures during the 4 weeks preceding the Selection Visit and were required to have >= 4 partial onset seizures during each 4-week interval of the Baseline Period to qualify for randomization
- unsatisfactory current AED treatment in terms of efficacy and/or safety
- stable AED treatment consisting of no more than two AEDs
- treatable seizure etiology
- epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
- history of status epilepticus which required hospitalization during 3 months prior to the Selection Visit
- history of or the presence of pseudo seizures
- current diagnosis of Lennox-Gastaut syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Subjects received Placebo matching to LEV treatment. Levetiracetam (LEV) Levetiracetam 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.
- Primary Outcome Measures
Name Time Method Partial onset seizure frequency (Type I, Type IC included) per week during the Treatment period During the 14-weeks Treatment period (Week 8 to Week 22) Calculated as 7-day partial onset seizure frequency.
- Secondary Outcome Measures
Name Time Method 50% responder rate in seizure frequency per week during the Treatment Period During the 14-weeks Treatment period (Week 8 to Week 22) 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.
Percent change from baseline in partial onset seizure frequency per week during the Treatment Period Baseline, During the 14-weeks Treatment period (Week 8 to Week 22) 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.Percent of patients with categorized reduction from baseline in seizure frequency per week during the Treatment Period From Baseline to the 14-weeks Treatment period Categories as follows: \<-25%, -25% to \<25%, 25% to \<50%, 50% to \<75%, 75% to \<100%, and 100%
Number of seizure free days during the Treatment Period During the 14-weeks Treatment period (Week 8 to Week 22) A day is regarded as seizure-free if no seizures are reported.
Absolute change from baseline in partial onset seizure frequency per week during the Titration Period Baseline, During the 6-weeks Titration period (Week 8 to Week 14) 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.Total seizure frequency per week (Types I + II + III) during the Treatment Period During the 14-weeks Treatment period (Week 8 to Week 22) Calculated as 7-day partial onset seizure frequency.
Total seizure frequency per week (Types I + II + III) during the Titration Period During the 6-weeks Titration period (Week 8 to Week 14) Calculated as 7-day partial onset seizure frequency.
Change from baseline in the average duration of seizure free intervals From Baseline to the 14-weeks Treatment period Intervals are defined as seizure-free if no seizures are reported.
Partial onset seizure frequency per week during the Titration Period During the 6-weeks Titration period (Week 8 to Week 14) Calculated as 7-day partial onset seizure frequency.
Absolute change from baseline in partial onset seizure frequency per week during the Treatment Period Baseline, During the 14-weeks Treatment period (Week 8 to Week 22) 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.Absolute change from baseline in partial onset seizure frequency per week during the Evaluation Period Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22) 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.Partial onset seizure frequency per week during the Evaluation Period During the 6-weeks Evaluation period (Week 8 to Week 14) Calculated as 7-day partial onset seizure frequency.
Percent change from baseline in partial onset seizure frequency per week during the Evaluation Period Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22) 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.Cumulative percentage of patients who were seizure-free since the beginning of the Evaluation Period Beginning of the Evaluation Period (Week 14) A subject was regarded as seizure-free if not seizures were reported since the beginning of the Evaluation Period.
Percent change from baseline in partial onset seizure frequency per week during the Titration Period Baseline, During the 6-weeks Titration period (Week 8 to Week 14) 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.Total seizure frequency per week (Types I + II + III) during the Evaluation Period During the 6-weeks Evaluation period (Week 8 to Week 14) Calculated as 7-day partial onset seizure frequency.