Rapamycin in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Myalgic Encephalomyelitis Clinical Trial

— ME/CFS  

Official title:

Rapamycin in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06257420
• Other study ID #: SRI-RP-2023-1
• Status: Enrolling by invitation
• Start date: December 11, 2023
• Est. completion date: June 11, 2026

Study information

• Verified date: April 2024
• Source: Simmaron Research Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to assess the clinical response and the effect of autophagy function in ME/CFS 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 ME/CFS and does it improve the quality of life?

• Does rapamycin change mTOR driven autophagy deficits observed in a subset of ME/CFS 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 11, 2026
• Est. primary completion date: December 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of ME/CFS that meets the Institute of Medicine (IOM) criteria

Exclusion Criteria:

• No diagnosis of ME/CFS

Related Conditions & MeSH terms

• Encephalomyelitis
• Fatigue Syndrome, Chronic
• Myalgia
• Myalgic Encephalomyelitis

Intervention

Drug:
• Rapamycin
Once weekly oral rapamycin

Locations

Country	Name	City	State
United States	Sierra Internal Medicine	Incline Village	Nevada
United States	Center For Complex Diseases	Palo Alto	California
United States	Bateman Horne Center	Salt Lake City	Utah
United States	Center For Complex Diseases	Seattle	Washington

Sponsors (6)

Lead Sponsor	Collaborator
Simmaron Research Inc.	Bateman Horne Center, Salt Lake City, UT, Center for Complex Diseases- Palo Alto, CA, Center For Complex Diseases-Seattle, WA, Sierra Internal Medicine, Incline Village, NV, Simmaron Research Inc. R&D Lab, University of Wisconsin, Milwaukee (UWM)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gottschalk CG, Whelan R, Peterson D, Roy A. Detection of Elevated Level of Tetrahydrobiopterin in Serum Samples of ME/CFS Patients with Orthostatic Intolerance: A Pilot Study. Int J Mol Sci. 2023 May 13;24(10):8713. doi: 10.3390/ijms24108713. — View Citation

Gottschalk G, Peterson D, Knox K, Maynard M, Whelan RJ, Roy A. Elevated ATG13 in serum of patients with ME/CFS stimulates oxidative stress response in microglial cells via activation of receptor for advanced glycation end products (RAGE). Mol Cell Neurosci. 2022 May;120:103731. doi: 10.1016/j.mcn.2022.103731. Epub 2022 Apr 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Short Form (36) Health Survey	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	1 year
Secondary	Change in mTOR activation panel and blood markers involved in autophagy function.	Change in concentrations of phosphorylated autophagy-related gene proteins in blood	1.5 year

External Links

•   Simmaron Website