At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 3 enrolled
Drug / intervention
Sirolimus +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.
Rapalogues for Autism Phenotype in TSC: A Feasibility Study
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.·interventional·Posted Aug 28, 2013·Updated Mar 29, 2021
In Brief
A Phase 2 clinical trial evaluating Sirolimus and Everolimus for Tuberous Sclerosis Complex and 2 related conditions. Completed, enrolled 3 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the feasibility and safety of administering rapalogues, sirolimus or everolimus, in participants with Tuberous Sclerosis Complex (TSC) and self-injury and to measure cognitive and behavioral changes, including reduction in autistic symptoms, self-injurious and aggressive behaviors, as well as improvements in cognition across multiple domains of cognitive function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberous Sclerosis Complex, Self-injury, Autism
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedAug 2013
Primary CompletionJul 2016
Study CompletionAug 2016
TodayJul 2026
First PostedAug 28, 2013
Enrollment StartJul 1, 2013
Primary CompletionJul 1, 2016
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 12.8 years ago
Interventions
Sirolimusdrug
Everolimusdrug