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NCT02338609 · ClinicalTrials.gov registry record · Phase 4
Long-term Monitoring of Growth and Development of Pediatric Patients Previously Treated With Everolimus
A Phase 4 study of Growth and Development, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
- 6
- Study locations
NCT02338609: Completed Phase 4 study of Growth and Development, sponsored by Novartis Pharmaceuticals.
NCT02338609 is a Phase 4 study of Growth and Development that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02338609, a Phase 4 study of Growth and Development, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
Tanner Staging, also known as Sexual Maturity Rating (SMR), is an objective classification system that providers use to document and track the development and sequence of secondary sex characteristics of children during puberty. Tanner Stage included two components for boys (testis and pubic hair) and two components for girls (breast development and pubic hair). Tanner Stage V: Males and females: Terminal hair that extends beyond the inguinal crease onto the thigh. Female Breast Development S
Conditions Studied
Interventions
- DRUG Everolimus
Study Locations (6)
Other
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Moscow
California
- University Of California LA SC - Los Angeles
Minnesota
- Minnesota Epilepsy Group - Saint Paul
Ohio
- Cinn Children Hosp Medical Center SC - Cincinnati
Texas
- Texas Scottish Rite Hos for Child SC - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-12-17 |
| Est. Completion | 2023-12-18 |
| Phase | Phase 4 |
What the finished NCT02338609 record still lists
NCT02338609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Growth and Development appearing as the primary indexed condition, and to 1 intervention - of which Everolimus is the first listed.
NCT02338609 lists 6 locations in 5 states (Other, California, Minnesota).
Frequently Asked Questions
What is clinical trial NCT02338609 about?
NCT02338609 is a clinical study titled "Long-term Monitoring of Growth and Development of Pediatric Patients Previously Treated With Everolimus". 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 mon...
What is the current status of trial NCT02338609?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2014-12-17. Estimated completion is 2023-12-18.
What conditions does trial NCT02338609 study?
This clinical trial studies the following conditions: Growth and Development.
What interventions are being tested in trial NCT02338609?
The interventions under investigation include: Everolimus (DRUG).
Who is sponsoring clinical trial NCT02338609?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02338609 being conducted?
This trial has 6 study locations across California, Minnesota, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02338609's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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