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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 is a Phase 4 study of Growth and Development that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 15 participants. The trial reports 6 study locations across 5 states.

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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.

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

FieldValue
Enrollment Target 15 participants
Start Date 2014-12-17
Est. Completion 2023-12-18
Phase Phase 4

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT02338609

The ClinicalTrials.gov registry entry for NCT02338609 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 5 distinct geographic areas - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.