Stanford University is working with K-PAX Pharmaceuticals to perform a double-blind, placebo-controlled trial to evaluate the safety and efficacy of a currently available FDA-approved medication co-administered with a novel mitochondrial support product in order to identify a safe and effective treatment for the chronic fatigue and concentration disturbance symptoms (i.e. brain fog) that commonly affect people with CFS.
The Synergy Trial (http://thesynergytrial.org) is currently enrolling over 120 subjects at four research sites throughout the United States. It is the largest double-blind, placebo-controlled pharmaceutical intervention trial in people with CFS to date. In addition to Stanford University, the other research sites include Salt Lake City, New York City, and Fort Lauderdale.
This randomized clinical trial is testing a combination of low-dose methylphenidate (generic Ritalin®) co-administered with a CFS mitochondrial support formula. This nutrient formula is a broad-spectrum micronutrient supplement designed to provide therapeutic dosages of key nutrients that support the functioning of the nervous, endocrine, and immune systems to a level at which co-administered methylphenidate can produce a positive effect on CFS symptoms.
When this treatment was previously given to 15 prospectively recruited patients as innovative therapy, a significant improvement in both fatigue and concentration disturbance symptoms (i.e. brain fog) occurred in greater than 50% of the patients in just 12 weeks.
The results of this trial will be presented at the International Chronic Fatigue Syndrome Biennial Conference (IACFS/ME) to be held at the Parc 55 Hotel in San Francisco this month (March 20-23). The main conference will be preceded by the Stanford 2014 Chronic Fatigue Syndrome Symposium to take place on March 19th at the Stanford University Campus.
Chronic Fatigue Syndrome (CFS) is a debilitating disease that currently affects over 2 million Americans and has no FDA-approved treatment. The FDA has identified CFS as "a serious unmet medical need" and specifically requested that pharmaceutical companies search for a safe and effective treatment.