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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. 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
  2. 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]
  3. Written informed consent according to local guidelines

EXCLUSION CRITERIA

Exclusion Criteria:


  1. 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
  2. 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
  3. Any patient who was pregnant prior to start of CRAD001M2305

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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 Details

Contition
Growth and Development
Age (in years)
< 17
Phase
PHASE4
Participants Needed
15
Est. Completion Date
Dec 18, 2023
Treatment Type
INTERVENTIONAL
Sponsor
Novartis
ClinicalTrials.gov NCT Identifier
NCT02338609
Study Number
CRAD001M2305

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