Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257420
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-26
First Post:
2024-01-17
Brief Title:
Rapamycin in Myalgic EncephalomyelitisChronic Fatigue Syndrome
Sponsor:
Simmaron Research Inc
Organization:
Simmaron Research Inc
Study Overview
Official Title:
Rapamycin in Myalgic EncephalomyelitisChronic Fatigue Syndrome
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MECFS
Brief Summary:
The goal of this observational study is to assess the clinical response and the effect of autophagy function in MECFS patients before during and throughout oral low dose sirolimus rapamycin therapy The main questions this study aims to answer are
Does rapamycin reduce the overall symptom burden of MECFS and does it improve the quality of life
Does rapamycin change mTOR driven autophagy deficits observed in a subset of MECFS patients
Participants will be asked to complete a series of questionnaires and quality of life instruments before starting rapamycin therapy prescribed by their physician and throughout their course of treatment Study blood samples will be collected before starting therapy and throughout the course of treatment to assess serological markers of autophagy
Does rapamycin reduce the overall symptom burden of MECFS and does it improve the quality of life
Does rapamycin change mTOR driven autophagy deficits observed in a subset of MECFS patients
Participants will be asked to complete a series of questionnaires and quality of life instruments before starting rapamycin therapy prescribed by their physician and throughout their course of treatment Study blood samples will be collected before starting therapy and throughout the course of treatment to assess serological markers of autophagy
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