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mTOR inhibitor

Everolimus for Tuberous Sclerosis Complex Growth Effects (EXIST-LT Trial)

Phase 4
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up annually up to 12 years
Awards & highlights

EXIST-LT Trial Summary

This trial will study the long-term effects of everolimus on growth, weight, and sexual development in children and adolescents with Tuberous Sclerosis Complex (TSC) associated with Subependymal Giant Cell Astrocytoma (SEGA).

Who is the study for?
This trial is for children and adolescents with TSC-associated SEGA who were previously in study CRAD001M2301. Girls under 16 and boys under 17, who haven't reached full sexual maturity (Tanner Stage V), are eligible. Pregnant individuals or those nearing the age cutoff within 3 months are excluded.Check my eligibility
What is being tested?
The trial monitors long-term effects of everolimus on growth, weight, and sexual development in pediatric patients with TSC-associated SEGA. It continues until participants reach full sexual maturity or the specified age limit.See study design
What are the potential side effects?
While not explicitly listed here, side effects may include those commonly associated with everolimus such as mouth ulcers, infections due to a weakened immune system, skin problems, and potentially delayed growth or puberty.

EXIST-LT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~annually up to 12 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and annually up to 12 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Height/Body Mass Index (BMI) standard deviation score since baseline
Mean Endocrine laboratory values
Secondary outcome measures
Age at Tanner Stage II, III, IV, V
Age at menarche/thelarche (females) or adrenarche (males)
Height/BMI standard deviation score by year since baseline
+3 more

Side effects data

From 2017 Phase 4 trial • 60 Patients • NCT02096107
20%
Hospitalization
20%
Immunosuppression held or modified
10%
Infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care
Low Intensity Tacrolimus

EXIST-LT Trial Design

2Treatment groups
Experimental Treatment
Group I: Physician ChoiceExperimental Treatment1 Intervention
Group II: EverolimusExperimental Treatment1 Intervention
All patients will have been previously treated with everolimus as part of CRAD001M2301. Continued treatment with everolimus is allowed but not required for participation in this study. However, the physician may choose to place the patient on another treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
2010
Completed Phase 4
~1510
Envirolimus drug class as prescribed by Physician
2014
Completed Phase 4
~20

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,863 Previous Clinical Trials
4,199,320 Total Patients Enrolled

Media Library

Everolimus (mTOR inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02338609 — Phase 4
Growth and Development Research Study Groups: Physician Choice, Everolimus
Growth and Development Clinical Trial 2023: Everolimus Highlights & Side Effects. Trial Name: NCT02338609 — Phase 4
Everolimus (mTOR inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02338609 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other experiments on record that have tested the effects of Everolimus?

"The first scientific trials of everolimus were conducted at Sheba Medical Center in 2008. In the present day, 93 active experiments are being administered and 405 have been concluded. Noteworthy locations include Saint Paul, Minnesota where numerous studies are presently running."

Answered by AI

What is the primary purpose of this medical research?

"This research trial aims to assess the Height/Body Mass Index (BMI) standard deviation score since baseline over a span of 12 years. Secondary objectives include monitoring Neuropsychological development with the TSC-Associated-Neuropsychiatric-Disorders (TAND) Checklist, gauging Long-term safety with National Cancer Institute’s Common Toxicity Criteria or Adverse Events (CTCAE), and tracking Age at menarche/thelarche for females or adrenarche for males. Additionally, data on concomitant medications and potential Adverse Events or Serious Adverse Events will be collected as necessary."

Answered by AI

Who meets the selection criteria for participating in this research?

"Candidates that wish to be included in this scientific investigation must have grown and developed between the ages of 0 and 17. Across 15 different centres, a total of 15 participants are being enrolled."

Answered by AI

To what extent does Everolimus pose a threat to patients?

"The safety of Everolimus was determined to be a 3 as this medication has been approved and is currently in Phase 4 trials."

Answered by AI

What is the cap on patient enrollment for this medical experiment?

"At this moment, recruitment for the specified clinical trial is not available. The last edit to its details was on December 3rd 2021 and it was initially posted on December 17th 2014. If other medical trials are being sought after, there exist three studies involving growth and development as well as 93 investigations recruiting patients with Everolimus."

Answered by AI

Is this trial enrolling new participants?

"This scientific study is not currently accepting patients. It was initially posted on December 17th 2014 and updated as recently as December 3rd 2021. For individuals looking for alternative medical trials, there are presently 3 growth & development studies recruiting and Everolimus has 93 active clinical trials searching for participants."

Answered by AI

How many medical centers are currently conducting this research experiment?

"Currently, Minnesota Epilepsy Group in Saint Paul, University of California at Los Angeles SC in LA and Texas Scottish Rite Hospital for Children SC in Dallas are all welcoming patients into the trial. Additionally, four other medical centres are also participating."

Answered by AI

Is the trial enrollment limited to individuals below a certain age?

"This study requires participants to be juvenescent, meaning they must not have reached their 18th birthday yet."

Answered by AI

In what common instances is Everolimus administered?

"Everolimus is typically implemented to prevent organ transplant rejection as well as treating Waldenström macroglobulinemia, lung cancer and advanced carcinoid tumors."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Long-term Follow-up for Growth and Development of Pediatric Patients From CRAD001M2301
2014. "Long-term Follow-up for Growth and Development of Pediatric Patients From CRAD001M2301". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02338609.
~1 spots leftby May 2025
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