Phase 2 Chronic Fatigue Syndrome Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) meeting specific recognized diagnostic criteria, including symptoms that get worse when standing or sitting upright.
- You are between 18 and 70 years old.
- Your symptoms started before December 2023.
- If you are a woman who could become pregnant, you agree to use contraception throughout the study.
- You are willing and able to follow all study requirements for the full length of the trial.
- Your body weight falls within a healthy range for your height (BMI between 17 and 40).
- You agree not to join any other clinical trial that involves a treatment or intervention while in this study.
- You have a working smartphone that can run a specific mobile app called DANA Brain Vital.
Who may not be able to join:
- You are pregnant, trying to become pregnant, or currently breastfeeding.
- You have used opioid (strong painkiller) medications in the last 30 days.
- You test positive for opioids in a urine test.
- You have a history of misusing alcohol, opioids, or other substances.
- You have taken part in another clinical trial involving a treatment in the last 30 days, or plan to during this study.
- You have a known allergy to the study medication or its ingredients.
- The study doctor believes you have a condition that makes it unsafe or unsuitable for you to participate (confirm with trial site).
- You have Type 1 or Type 2 diabetes.
- You have been admitted to a hospital in the last 30 days, or have a planned hospital stay or surgery during the study period that may affect results.
- You have a significant lung condition (such as COPD, cystic fibrosis, severe asthma, tuberculosis, pulmonary fibrosis, or lung cancer) or a significant heart condition.
- You have an active cancer or have been recently treated for cancer.
- You have started a new exercise routine within the last 4 weeks before joining the study.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: David Systrom, MD, Massachusetts General Hospital
Phone: 617-525-6797
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Functional Capacity; Physiologic Response - Oxygen Uptake Efficiency Slope (OUES); Physiologic Response - Oxygen Utilization (VO2); Physiologic Response - Heart Rate Recovery (HRR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.