Tuberous Sclerosis Complex, Epilepsy, Tumors associated with Tuberous Sclerosis Complex
Conditions
Brief summary
occurrence of clinical seizures in the blinded phase of the study, increase in summarized volume of TSC-associated tumors ≥ 25% of initial value within the blinded phase of the study.
Detailed description
time from birth to onset of first clinical epileptic seizure, total volume of TSC-associated tumors within the blinded phase and the whole study, the risk for high risk of autism assessed with psychological test (ADOS) at the end of the study, the risk for low developmental quotient (< 70 points in Bayley Scales of Infant Development,) at the end of the study,, the risk of drug-resistant epilepsy at any point of the study, occurrence of adverse events within the blinded phase of the study,, number of adverse events across the whole study, parameters of physical development (weight and height gain history) across the whole study., Parameters of vital signs (body temperature, pulse rate, respiraton rate and blood pressure)
Interventions
Sponsors
Instytut Pomnik Centrum Zdrowia Dziecka
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| occurrence of clinical seizures in the blinded phase of the study, increase in summarized volume of TSC-associated tumors ≥ 25% of initial value within the blinded phase of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| time from birth to onset of first clinical epileptic seizure, total volume of TSC-associated tumors within the blinded phase and the whole study, the risk for high risk of autism assessed with psychological test (ADOS) at the end of the study, the risk for low developmental quotient (< 70 points in Bayley Scales of Infant Development,) at the end of the study,, the risk of drug-resistant epilepsy at any point of the study, occurrence of adverse events within the blinded phase of the study,, number of adverse events across the whole study, parameters of physical development (weight and height gain history) across the whole study., Parameters of vital signs (body temperature, pulse rate, respiraton rate and blood pressure) | — |
Countries
Poland
Outcome results
None listed