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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 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.

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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.

Interventions

  • DRUG Sirolimus
  • DRUG Everolimus

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2013-07
Est. Completion 2016-08
Phase Phase 2

What the Registry Record Tells You About NCT01929642

The ClinicalTrials.gov registry entry for NCT01929642 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Sirolimus is the first listed.

NCT01929642 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.