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

Completed · Phase 4

Conditions studied: Growth and Development

In brief

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.

Key facts

Study ID

NCT02338609

Run by

Novartis Pharmaceuticals

People needed

15

Starts

2014-12-17

Expected to finish

2023-12-18

Last updated by the study team

2024-08-09

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric female patients who were on study treatment in study [CRAD001M2301] within the past 6 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

You may not qualify if…

• 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

Where it is running

• University Of California LA SC — Los Angeles, California, United States
• Minnesota Epilepsy Group — Saint Paul, Minnesota, United States
• Cinn Children Hosp Medical Center SC — Cincinnati, Ohio, United States
• Texas Scottish Rite Hos for Child SC — Dallas, Texas, United States
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Moscow, Russia

Full record on ClinicalTrials.gov

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