Focal-onset Seizures, Primary generalized tonic-clonic seizures
Conditions
Brief summary
Severity and frequency of TEAEs, SAEs, AESIs, AEDCs, AEs leading to dose reduction, and ECIs; potentially clinically significant changes in vital signs, clinical laboratory findings, and/or 12-lead ECG; changes in ophthalmologic exams; increase in suicide risk as assessed by the C-SSRS; clinically significant changes in urological symptoms (including retention) as measured by the AUA-SI; and growth and development in adolescents assessed via physical exam and endocrine laboratory assessments.
Detailed description
Percent change in monthly seizure rate recorded at baseline (in the antecedent studies) compared to each 4-week assessment period in the treatment period in X-TOLE4., Proportion of responders (subjects experiencing ≥50% reduction in seizure frequency from baseline) in each consecutive 4-week assessment period of the treatment period of the OLE study, Change in CGI‑S and PGI-S scores over time., Change in the QOLIE-31 over time.
Interventions
DRUGXPF-010
Sponsors
Xenon Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity and frequency of TEAEs, SAEs, AESIs, AEDCs, AEs leading to dose reduction, and ECIs; potentially clinically significant changes in vital signs, clinical laboratory findings, and/or 12-lead ECG; changes in ophthalmologic exams; increase in suicide risk as assessed by the C-SSRS; clinically significant changes in urological symptoms (including retention) as measured by the AUA-SI; and growth and development in adolescents assessed via physical exam and endocrine laboratory assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in monthly seizure rate recorded at baseline (in the antecedent studies) compared to each 4-week assessment period in the treatment period in X-TOLE4., Proportion of responders (subjects experiencing ≥50% reduction in seizure frequency from baseline) in each consecutive 4-week assessment period of the treatment period of the OLE study, Change in CGI‑S and PGI-S scores over time., Change in the QOLIE-31 over time. | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Poland, Portugal, Spain
Outcome results
None listed