Clinical Trials Logo

Clinical Trial Summary

The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-65 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance. This double-blind, placebo-controlled study will involve 160 participants randomized into one of four possible groups: Pyridostigmine/LDN (40), Pyridostigmine/Placebo (40), LDN/Placebo (40), Placebo/Placebo (40). The dose of Pyridostigmine will be carefully titrated from 30mg to 60mg three times a day, and the dose of LDN will be titrated from 1.5 mg to 4.5 mg once daily. The trial includes a scale-back plan, allowing participants to reduce their dosage if they experience intolerance symptoms, with adjustments made during weekly visits. This plan provides a personalized approach to medication tolerance, ensuring participant's safety and comfort throughout the trial. The time commitment for the participant is approximately three (3) months, and during this time, there will be three (3) in-person visits to BWH and four (4) virtual visits. Study procedures will include two (2) submaximum cardiopulmonary exercise tests, questionnaires (virtually completed), and blood and urine collection. We will be recruiting from the BWH Dyspnea Clinic as well as the Open Medicine Foundation (OMF) StudyME Registry and anticipate the entire trial will take two (2) years to complete. The LIFT represents a significant endeavor to improve treatment options for ME/CFS patients and contribute to the broader understanding of this debilitating condition.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06366724
Study type Interventional
Source Brigham and Women's Hospital
Contact Research Coordinator
Phone 617-525-6797
Email jsquires1@bwh.harvard.edu
Status Not yet recruiting
Phase Phase 2
Start date July 2024
Completion date June 2026

See also
  Status Clinical Trial Phase
Recruiting NCT03952624 - Patient-Centered Assessment of Symptoms and Outcomes
Recruiting NCT05710770 - Immunoadsorption in Patients With Chronic Fatigue Syndrome Including Patients With Post-COVID-19 CFS N/A
Recruiting NCT05778006 - Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (ME/CFS) Registry and Biobank, COVID-19, SARS-CoV-2
Recruiting NCT06072287 - The Living With a Long-Term Condition Study
Recruiting NCT04806620 - Solve Together: A Data Collection Platform for the Collection of Patient and Control Health Information to Support Future Research That Will Accelerate Understanding of the Causes of and Possible Treatments for ME/CFS and Other Chronic Diseases, Including Post-viral Illnesses
Recruiting NCT05225688 - Skeletal Muscle in PASC and ME/CFS Patients
Recruiting NCT06211062 - The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Phase 2
Active, not recruiting NCT04610515 - Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE)