Adult focal (partial onset) epilepsy
Conditions
Brief summary
1. Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo., 2. Severity and frequency of associated AEs/SAEs, clinically significant changes in clinical laboratory findings and/or 12-lead ECG, increase in suicide risk as assessed by the C-SSRS Scale including increase in suicidal thoughts or an attempt, clinically significant changes in vital signs including blood pressure, pulse, or weight, and clinically significant changes in urological symptoms including retention as measured by the AUA-SI in the DBP.
Detailed description
3. Responders are defined as subjects experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline compared to DBP., 4. Percent change from baseline in weekly focal seizure frequency for each week in the DBP., 5. CGI-C and PGI-C scores during the DBP.
Sponsors
Xenon Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo., 2. Severity and frequency of associated AEs/SAEs, clinically significant changes in clinical laboratory findings and/or 12-lead ECG, increase in suicide risk as assessed by the C-SSRS Scale including increase in suicidal thoughts or an attempt, clinically significant changes in vital signs including blood pressure, pulse, or weight, and clinically significant changes in urological symptoms including retention as measured by the AUA-SI in the DBP. | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. Responders are defined as subjects experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline compared to DBP., 4. Percent change from baseline in weekly focal seizure frequency for each week in the DBP., 5. CGI-C and PGI-C scores during the DBP. | — |
Countries
Germany, Italy, Spain
Outcome results
None listed