Refractory Partial Onset Epilepsy
Conditions
Brief summary
Percent change from baseline* in FOS frequency per week over the 12 week double-blind period.
Detailed description
Change from baseline* in absolute FOS over the 12 week double-blind period., Proportion of subjects with at least 50% reduction from baseline* in total seizure frequency per week over the 12 week double-blind period., Proportion of subjects with at least 50% reduction from baseline* in total seizures over the 12 week double-blind period., Number of days free of FOS over the treatment period of 12 weeks., Response in Weekly FOS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks)., Change in the Quality of Life in Epilepsy (QoLIE-31) scale score (patients ≥18 years) and QoLIE- AD-48 (age <18 years) over the study period., Improving medication compliance and patient satisfaction with the treatment over the study period.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline* in FOS frequency per week over the 12 week double-blind period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline* in absolute FOS over the 12 week double-blind period., Proportion of subjects with at least 50% reduction from baseline* in total seizure frequency per week over the 12 week double-blind period., Proportion of subjects with at least 50% reduction from baseline* in total seizures over the 12 week double-blind period., Number of days free of FOS over the treatment period of 12 weeks., Response in Weekly FOS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks)., Change in the Quality of Life in Epilepsy (QoLIE-31) scale score (patients ≥18 years) and QoLIE- AD-48 (age <18 years) over the study period., Improving medication compliance and patient satisfaction with the treatment over the study period. | — |
Countries
Bulgaria, Czechia, Germany, Greece, Hungary, Italy, Poland, Romania, Spain