Clinical trial registry record

Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)

A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.

Plain-language guide

Five questions to ask about this record

What this is
A clinical study registration, not a result or recommendation.
Why it may matter
The registry currently reports Completed.
Evidence
Registered phase 3 study.
Main limitation
Registration does not prove that the intervention works, is safe, or is available to you.
What changed
Registry metadata was last updated February 3, 2016.
Where to verify
Open the primary registry below for eligibility, locations, contacts, and current status.
Registry ID
NCT00789828
Last registry update
February 3, 2016
Status
Completed
Phase
Phase 3
Sponsor
Novartis Pharmaceuticals
Enrollment
117
Countries
United States, Australia, Belgium, Canada, Germany, Italy, Netherlands, Poland, Russia, United Kingdom
Match confidence
100%
Source feed
ClinicalTrials.gov
Automated source synopsis

A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.

Evidence snapshot

What the source actually supports

Evidence stage
Phase 3
Study design
RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE
Evidence population
Human clinical study registration
Participants
117
Population
ALL
Duration
2009-08-01 to 2014-10-01
Intervention
Everolimus; Placebo
Comparator
Placebo
Outcomes measured
Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response — End of core period…; Change From Baseline in Frequency of Total Seizure Events Per 24 Hours at Week 24 in Both Core and Extension Period — B…; Time to SEGA Progression — Baseline up to week 48 (end of core period), and end of extension period (up to 4 years); Time to SEGA Response — Baseline up to week 48 (end of core period), and end of extension period (up to 4 years); Duration of SEGA Response — Baseline up to week 48 (end of core period), and end of extension period (up to 4 years); Time to SEGA Worsening — Baseline up to week 48 (end of core period), and end of extension period (up to 4 years); Percentage of Participants With Skin Lesions Assessed Using Physician's Global Assessement Overall Score — End of core…; Duration of Skin Lesion Response in Everolimus Treated Participants — Baseline up to week 48 (end of core period), and…; Everolimus Blood Concentration (C2h) at 2 Hours Post Dose — 2 hours post dose on Week 6, Week 24, Week 48, Week 96, Wee…; Everolimus Trough Concentrations (Cmin) at 24 Hours After Last Dose — 24 hours post dose on Week 6, Week 24, Week 48, W…; Percentage of Participants With Renal Impairment During Core Period — Day 1 up to 28 days after end of treatment (Core…
Reported result
No reusable finding-level result is available in this record.

Main limitationThis is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.

Safety and approvalEligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians. Trial registration is not regulatory approval and does not establish that an intervention is available.

Source supportStructured registry protocol metadata; no finding-level conclusion is generated.

Trial stage · Phase 3A trial phase describes development stage; it does not establish a positive result.
Phase 1Phase 2Phase 3Phase 4

Registration and recruitment status do not establish safety, efficacy, or regulatory approval.

Why this record appears here · 100% topic match

The title, summary, or source keywords matched one or more topics followed by immortal.life. A higher percentage means a stronger topic match; it does not rate safety, effectiveness, or study quality.

  • Rapamycin · 100%Title contains controlled topic terminology. Summary contains controlled topic terminology. Source terminology contains a controlled topic term.

Automated source check 100% · update recency 35%. These figures help sort records; they are not medical ratings.

rapamycin
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