Epilepsy
Conditions
Keywords
Levetiracetam, Keppra
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.
Interventions
DRUGLevetiracetam
* high total tablet weight (HTTW) formulation in tablet strengths of 166.5 mg, 250 mg, and 500 mg was used for patients weighing at least 40.1 kg * low total tablet weight (LTTW) formulation in tablet strengths of 166 mg and 250 mg was used for patients weighing 40 kg or less
DRUGPlacebo
Placebo tablets for oral administration that were identical in appearance to the respective formulations (LTTW and HTTW) were used as reference therapy
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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% |
| 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. |
| 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 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 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. |
| 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. |
| 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 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Outcome results
None listed