Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06080165
Status:
WITHDRAWN
Last Update Posted:
2024-07-10
First Post:
2023-09-29
Brief Title:
Sirolimus for Improving Social Abilities in People With PTEN Germline Mutations
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
A Randomized Controlled Double-Blind Trial of Sirolimus for Improving Social Abilities in People With PTEN Germline Mutations
Status:
WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator decided not to proceed with the trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to examine the safety and treatment effects of sirolimus for targeting social communication deficits in people with genetic disorders associated with PTEN germline mutations which are often referred to as PTEN Harmartoma Tumor Syndrome PHTS The mechanism of sirolimus in the body has shown promise for helping to improve social communication skills in case reports of people with PHTS Everolimus a closely related compound also showed benefits in social communication skills in a previous pilot trial in people with PHTS This is a 6 month double-blind trial followed by at 6 month open label extension trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None