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NCT01929642 · ClinicalTrials.gov registry record · Phase 2
Rapalogues for Autism Phenotype in TSC: A Feasibility Study
A Phase 2 study, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- Completed
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01929642: Completed Phase 2 study, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
NCT01929642 is a Phase 2 study that has completed, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01929642, a Phase 2 study, has completed, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study 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.
Primary Outcome
One outcome measurement of feasibility will include family/patient compliance with the treatment protocol, which will be assessed and documented at every study visit and telephone follow-up call, by the physician and/or study team member. This was calculated by calculating dividing the total number of study visits and study assessments completed by the total number of study visits and study assessments indicated by the treatment protocol.
Interventions
- DRUG Sirolimus
- DRUG Everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
What the finished NCT01929642 record still lists
NCT01929642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Sirolimus is the first listed.
NCT01929642 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01929642 about?
NCT01929642 is a clinical study titled "Rapalogues for Autism Phenotype in TSC: A Feasibility Study". 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 ...
What is the current status of trial NCT01929642?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2013-07. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01929642?
The interventions under investigation include: Sirolimus (DRUG), Everolimus (DRUG).
Who is sponsoring clinical trial NCT01929642?
This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01929642's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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