tuberous sclerosis complex, epilepsy, organ tumors associated with tuberous sclerosis
Conditions
Brief summary
comparison of the number of patients with at least 50% reduction of seizures per week in the last month of the core blinded phase in comparison to screening phase in the rapamycin vs placebo group (, number of adverse events (according to CTCAE classification) in the rapamycin vs placebo group during the double-blind core phase
Detailed description
comparison of the number of seizures per week and the number of days free of seizures in the rapamycin vs placebo group, during 12-week treatment in double-blind core phase, severity of adverse events (according to CTCAE) and the number of patients withdrawn from the study due to adverse events in the rapamycin vs placebo group
Interventions
Sponsors
Instytut Pomnik Centrum Zdrowia Dziecka
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| comparison of the number of patients with at least 50% reduction of seizures per week in the last month of the core blinded phase in comparison to screening phase in the rapamycin vs placebo group (, number of adverse events (according to CTCAE classification) in the rapamycin vs placebo group during the double-blind core phase | — |
Secondary
| Measure | Time frame |
|---|---|
| comparison of the number of seizures per week and the number of days free of seizures in the rapamycin vs placebo group, during 12-week treatment in double-blind core phase, severity of adverse events (according to CTCAE) and the number of patients withdrawn from the study due to adverse events in the rapamycin vs placebo group | — |
Countries
Poland
Outcome results
None listed