Tuberous Sclerosis Complex (TSC) related epilepsy
Conditions
Brief summary
Incidence and severity of AEs, SAEs and withdrawals and dose-reductions due to AEs., Vital sign measurements including blood pressure, heart rate, respiratory rate, body temperature, height, and body weight., Physical, neurological, and developmental examination., 12-lead ECG., Clinical laboratory tests., C-SSRS.
Detailed description
Percentage change from baseline in 28-day seizure frequency during open-label treatment. (first year only), Percentage change from baseline in 28-day seizure frequency during the long-term treatment. (first year only), Number (%) of participants considered treatment responders. (first year only), CGI-I at the last scheduled study visit., Change from baseline in the quality-of-life scale SF-36. (first year only), Change from baseline in the percentage of seizure-free days during treatment, based on seizure type. (first year only), Change from baseline of CGI-CSID.
Interventions
DRUGGanaxolone
Sponsors
Marinus Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of AEs, SAEs and withdrawals and dose-reductions due to AEs., Vital sign measurements including blood pressure, heart rate, respiratory rate, body temperature, height, and body weight., Physical, neurological, and developmental examination., 12-lead ECG., Clinical laboratory tests., C-SSRS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in 28-day seizure frequency during open-label treatment. (first year only), Percentage change from baseline in 28-day seizure frequency during the long-term treatment. (first year only), Number (%) of participants considered treatment responders. (first year only), CGI-I at the last scheduled study visit., Change from baseline in the quality-of-life scale SF-36. (first year only), Change from baseline in the percentage of seizure-free days during treatment, based on seizure type. (first year only), Change from baseline of CGI-CSID. | — |
Countries
Belgium, France, Germany, Italy, Spain
Outcome results
None listed