At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 117 enrolled
Drug / intervention
Everolimus +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Study of Everolimus in the Treatment of Patients With Subependymal Giant Cell Astrocytomas (SEGA) Associated With Tuberous Sclerosis Complex (TSC)
In Brief
A Phase 3 clinical trial evaluating Everolimus and Placebo for Tuberous Sclerosis and Subependymal Giant Cell Astrocytoma. Completed, enrolled 117 participants across 24 sites in 10 countries.
Detailed Summary
This study evaluated the efficacy and safety of Everolimus in treating patients with Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Canada, Germany, Italy, Netherlands, Poland, Russia, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartAug 2009
Primary CompletionMar 2011
Study CompletionOct 2014
TodayJul 2026
First PostedNov 13, 2008
Enrollment StartAug 1, 2009
Primary CompletionMar 1, 2011
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.6 years ago
Interventions
Everolimusdrug
Everolimus was formulated as tablets of 1.0-mg strength and was blisterpacked under aluminum foil in units of 10 tablets.
Placebodrug
Placebo was provided as a matching tablet and was blisterpacked under aluminum foil in units of 10.