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New treatment option for ME/CFS
Official title LIFT: Life Improvement Trial
ClinicalTrials.gov ID: NCT06366724
What this study is testing
What is Pyridostigmine?
Pyridostigmine is an investigational medicine, given as an once-weekly, being studied as a potential treatment for me/cfs.
Also referred to as Mestinon.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Meet National Academy of Medicine Criteria, Canadian Consensus Criteria (See appendix), and demonstrate orthostatic intolerance for diagnosis of...
- Participant is ≥ 18 and ≤ 70 years of age at screening, inclusive.
- The onset of symptoms prior to December 2023.
- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential
You likely can't join if
- Pregnant, planning to become pregnant, or breastfeeding.
- Any use of opioid medications within 30 days of screening.
- Positive urine test for opioids
- History of alcohol, opioid or other substance misuse
- Participation in another treatment clinical trial in the last 30 days or planned during the trial period.
- Allergy to medication components
See the full eligibility criteria
- Meet National Academy of Medicine Criteria, Canadian Consensus Criteria (See appendix), and demonstrate orthostatic intolerance for diagnosis of ME/CFS
- Participant is ≥ 18 and ≤ 70 years of age at screening, inclusive.
- The onset of symptoms prior to December 2023.
- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential
- Woman of childbearing potential who agrees to follow the contraceptive guidance. from the time of informed consent.
- Participant agrees and can adhere to the study requirements for the length of the study.
- Participant has a body mass index (BMI) range of 17 to 40 kg/m2, inclusive.
- Participant agrees not to participate in another treatment study while participating in the present study.
- Participant has a functioning smart phone to download and run the DANA Brain Vital Mobile Application.
- Pregnant, planning to become pregnant, or breastfeeding.
- Any use of opioid medications within 30 days of screening.
- Positive urine test for opioids
- History of alcohol, opioid or other substance misuse
- Participation in another treatment clinical trial in the last 30 days or planned during the trial period.
- Allergy to medication components
- Participant has any condition which, in the investigator's opinion, makes the participant unsuitable for study participation.
- Participant has diabetes mellitus (type 1 or 2).
- 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...
- Participant has clinically significant respiratory disease (such as chronic obstructive pulmonary disease, cystic fibrosis, severe asthma, lung infections including tuberculosis, sarcoidosis, thoracic endometriosis...
- Participant has an active malignancy or any other cancer.
- Participant has initiated an exercise regimen within 4 weeks prior to randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.