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NCT00789828 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 117
- Enrollment target
NCT00789828: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00789828 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 117 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00789828, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 117 participants
- Enrollment target
Study Summary
This study evaluated the efficacy and safety of Everolimus in treating patients with Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex.
Primary Outcome
Participants were assessed for SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilized to identify SEGA lesions. SEGA response rate was def
Interventions
- DRUG Placebo
- DRUG Everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2009-08 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT00789828 record still lists
NCT00789828 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00789828 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00789828 about?
NCT00789828 is a clinical study titled "Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)". This study evaluated the efficacy and safety of Everolimus in treating patients with Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex.
What is the current status of trial NCT00789828?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 117 participants. The study started on 2009-08. Estimated completion is 2014-10.
What interventions are being tested in trial NCT00789828?
The interventions under investigation include: Placebo (DRUG), Everolimus (DRUG).
Who is sponsoring clinical trial NCT00789828?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00789828's enrollment target sits among peer trials
117 1642nd of 2000 higher than 358 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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