| NCT ID | NCT06366724 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | ME/CFS |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-09-10 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2024-09-10 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 18-70 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance (OI). Long COVID (LC) subjects will also be included if they meet CCC and have OI. 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.
Eligibility Criteria
Inclusion Criteria: 1. Meet National Academy of Medicine Criteria, Canadian Consensus Criteria (See appendix), and demonstrate orthostatic intolerance for diagnosis of ME/CFS 2. Participant is ≥ 18 and ≤ 70 years of age at screening, inclusive. 3. The onset of symptoms prior to December 2023. 4. Female participant is not pregnant and at least 1 of the following conditions apply: 1. Not a woman of childbearing potential 2. Woman of childbearing potential who agrees to follow the contraceptive guidance. from the time of informed consent. 5. Participant agrees and can adhere to the study requirements for the length of the study. 6. Participant has a body mass index (BMI) range of 17 to 40 kg/m2, inclusive. 7. Participant agrees not to participate in another interventional study while participating in the present study. 8. Participant has a functioning smart phone to download and run the DANA Brain Vital Mobile Application. Exclusion Criteria: 1. Pregnant, planning to become pregnant, or breastfeeding. 2. Any use of opioid medications within 30 days of screening. 3. Positive urine test for opioids 4. History of alcohol, opioid or other substance misuse 5. Participation in another interventional clinical trial in the last 30 days or planned during the trial period. 6. Allergy to medication components 7. Participant has any condition which, in the investigator's opinion, makes the participant unsuitable for study participation. 8. Participant has diabetes mellitus (type 1 or 2). 9. Participant has undergone an inpatient hospitalization within the 30 days prior to the randomization or has a planned hospitalization or a surgical procedure during the study, which may affect the study assessments, in the opinion of the investigator. 10. Participant has clinically significant respiratory disease (such as chronic obstructive pulmonary disease, cystic fibrosis, severe asthma, lung infections including tuberculosis, sarcoidosis, thoracic endometriosis, pulmonary fibrosis, and lung cancers) and/or cardiac disease (medical history or current clinical findings) 11. Participant has an active malignancy or any other cancer. 12. Participant has initiated an exercise regimen within 4 weeks prior to randomization.
Contact & Investigator
David Systrom, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06366724 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying ME/CFS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06366724 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06366724 currently recruiting?
Yes, NCT06366724 is actively recruiting participants. Contact the research team at jsquires1@bwh.harvard.edu for enrollment information.
Where is the NCT06366724 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06366724 clinical trial?
NCT06366724 is sponsored by Brigham and Women's Hospital. The principal investigator is David Systrom, MD at Massachusetts General Hospital. The trial plans to enroll 160 participants.