Overview

Long-term Follow-up for Growth and Development of Pediatric Patients From CRAD001M2301

Status:
Active, not recruiting
Trial end date:
2026-09-25
Target enrollment:
Participant gender:
Summary
The primary objective of CRAD001M2305 is 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 will monitor the growth and development of pediatric patients with TSC-associated SEGA, previously enrolled in CRAD001M2301 until they reach Tanner Stage V, or until age 16 for females or 17 for males whichever occurs first.
Phase:
Phase 4
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Everolimus
Sirolimus