MILL VALLEY, Calif., Feb. 26, 2014 /PRNewswire/ — K-PAX Pharmaceuticals is working with Stanford University and several other leading research institutions to perform a Phase II double-blind, placebo-controlled trial to evaluate the safety and efficacy of a currently available FDA-approved medication concurrently administered with a novel mitochondrial support product in order to identify a safe and effective treatment for the chronic fatigue and decreased alertness (i.e. brain fog) that commonly afflicts people with CFS.
The Synergy Trial (http://thesynergytrial.org) will enroll 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 Nova Southeastern University in Fort Lauderdale, Florida.
This randomized clinical trial will test a combination of a low-dose CNS stimulant (methylphenidate – a generic version of 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 concomitantly administered methylphenidate can produce a positive effect on CFS symptoms.
When this treatment was previously administered to 15 prospectively recruited patients as innovative therapy, it produced encouraging results resulting in a significant improvement in both fatigue and concentration disturbance symptoms (i.e. brain fog) as measured by the Checklist Individual Strength (CIS), a validated research tool used to assess fatigue in patients with Chronic Fatigue Syndrome. This improvement occurred in greater than 50% of the CFS patients after just 12 weeks. Based upon these results, K-PAX Pharmaceuticals is pursuing further investigation of this potentially promising therapy.
Chronic Fatigue Syndrome (CFS) is a debilitating disease that currently affects over 2 million Americans and has no FDA-approved treatments. The FDA has identified CFS as “a serious unmet medical need” and specifically requested that pharmaceutical companies search for a safe and effective treatment.
K-PAX Pharmaceuticals, based in Mill Valley, California, is a privately-held biotechnology company pioneering medicines to strengthen immune function and support optimal energy metabolism. Learn more here.