Long-term Follow-up for Growth and Development of Pediatric Patients From CRAD001M2301
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Pediatric female patients who were on study treatment in study [CRAD001M2301] within the past 63 months and have not reached Tanner Stage V or age 16 at the time of completion of [CRAD001M2301] or
- Pediatric male patients who were on study treatment in study [CRAD001M2301] within the past 6 months and have not reached Tanner Stage V or age 17 at the time of completion of [CRAD001M2301]
- Written informed consent according to local guidelines
EXCLUSION CRITERIA
Exclusion Criteria:
- Pediatric female patients who were on study treatment in CRAD001M2301 and have not reached Tanner Stage V but are within 3 month of turning age 16 or
- Pediatric male patients who were on study treatment in CRAD001M2301 and have not reached Tanner Stage V but are within 3 months of turning age 17
- Any patient who was pregnant prior to start of CRAD001M2305
Other protocol-defined Inclusion/Exclusion criteria
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Growth and Development
Age (in years)
< 17
Phase
Phase 4
Participants needed
15
Est. Completion Date
Sep 25, 2026
Treatment type
Interventional
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT02338609
Study number
CRAD001M2305
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