drugset / Trial / NCT02338609

Long-term Monitoring of Growth and Development of Pediatric Patients Previously Treated With Everolimus

NCT02338609

Phase 4 Completed 15 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelOther

Summary

The primary objective of CRAD001M2305 was to report the long-term effects of everolimus treatment on height, weight and sexual development (using Tanner Stages) in children and adolescents with Tuberous Sclerosis Complex (TSC)-associated with Subependymal Giant Cell Astrocytoma (SEGA). The study monitored the growth and development of pediatric patients with TSC-associated SEGA, previously enrolled in CRAD001M2301 (NCT00789828) until they reach Tanner Stage V, or until age 16 for females or 17 for males whichever occurred first.

Timeline

Start
2014-12-17
Primary completion
2023-12-18
Completion
2023-12-18

Drugs

EvaluationDrugModalityDoseRoute
Background Everolimus Small molecule

Indications

No indication recorded.