We are thrilled to announce our very first clinical trial: The Life Improvement Trial (LIFT). This clinical treatment trial is a major step towards understanding and treating Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) more effectively.
What is The LIFT?
Conducted under the direction of David Systrom, MD, Director of our Harvard Collaboration and Jonas Bergquist, MD, PhD, OMF’s Chief Medical Officer and Director of the Uppsala University Collaboration, The LIFT is a randomized, double-blind placebo trial that will investigate two particular drugs: Pyridostigmine (commonly known as Mestinon) and low-dose naltrexone (LDN) separately and together as a combination.
Jonas Bergquist, MD, PhD, (left), David Systrom, MD (right)
Why LDN and Mestinon?
Anecdotally, both have demonstrated potential as off-label treatments, each offering its distinct advantages. For example, LDN has been a ray of hope for many, mitigating symptoms such as brain fog and fatigue. On the other hand, Mestinon (Pyridostigmine) has demonstrated its effectiveness in reducing Postural Orthostatic Tachycardia Syndrome (POTS).
In a self-reported patient treatment survey, involving over 3,800 ME/CFS and Long COVID patients, these drugs showed significant benefits. Now, our LIFT trial seeks to scientifically validate these findings by testing the safety and efficacy of these treatments so that others may be able to benefit from these treatments as well.
The primary focus? To assess the effectiveness of these drugs in reducing symptoms like brain fog, fatigue, post-exertional malaise, and postural orthostatic tachycardia syndrome (POTS). Importantly, this trial will establish the infrastructure for future clinical treatment trials funded by OMF.
Here’s where it gets even more exciting. The LIFT trial doesn’t just look at improved symptoms. It is important to have measurable outcomes and will integrate molecular assays as well as evaluate changes in functional capacity.
This in-depth look allows our research team to closely monitor the patient’s response to each arm of the drug treatment in a way that’s masked (double-blinded) to ensure unbiased results. By doing this, we can pin down how these drugs might work at the very core and develop ways to predict which patients might benefit the most. Think of it as tailoring the treatment to fit the individual perfectly – that’s what we call precision medicine in ME/CFS.
Why This Matters
With the support of OMF, The LIFT trial presents a golden opportunity. By studying the effects of Low Dose Naltrexone (LDN) and Mestinon in combination and separately, we’re paving the way for understanding how these, and potentially other FDA-approved drugs, might benefit ME/CFS patients in the future. Ultimately, this trial will kick off the infrastructure for a future of other clinical treatment trials, thereby speeding up the path to finding effective treatments.
When does the trial start and how are we recruiting?
This trial is planned to start before the end of the year. David Systrom and Jonas Bergquist are the lead investigators and will be recruiting from their patients in the Boston area as well as participants who have signed up through OMF’s StudyME as needed.
Join Our Mission
The success of The LIFT trial and our future clinical trials significantly depend on the collective support from our community. Your donation can make a monumental difference.
Sign up for OMF’s StudyME to be alerted when researchers recruit for studies like this.
Whether opportunities are near you or available virtually, we’ll alert you directly via email when researchers need your participation. Join StudyME today and contribute to the discoveries of tomorrow! Join from anywhere in the world — it takes less than 5 minutes and no personal medical information is required.