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Clinical trial

Rapamycin in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

ID
Name
SRI-RP-2023-1
Description
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.
Trial arms
Trial start
2023-12-11
Estimated PCD
2025-12-11
Trial end
2026-06-11
Treatment
Rapamycin
Once weekly oral rapamycin
Arms:
ME/CFS patients with serological evidence of autophagy disruption, ME/CFS patients without serological evidence of autophagy disruption
Other names:
Sirolimus, Rapamune
Size
100
Primary endpoint
The Short Form (36) Health Survey
1 year
Eligibility criteria
Inclusion Criteria: * Diagnosis of ME/CFS that meets the Institute of Medicine (IOM) criteria Exclusion Criteria: * No diagnosis of ME/CFS
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood will be collected to isolate plasma, PBMC, serum and RNA.'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-04-26

1 organization

1 product

1 indication

Organization
Simmaron Research
Product
Rapamycin
Indication
Chronic Fatigue Syndrome