US-based K-PAX Pharmaceuticals is collaborating with Stanford University and several other research institutions to carry out a Phase II double-blind, placebo-controlled Synergy study for the treatment of chronic fatigue syndrome (CFS).
The study is designed to assess 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 chronic fatigue and decreased alertness that commonly troubles people with CFS.
Around 120 subjects will be enrolled in the double-blind, placebo-controlled pharmaceutical intervention trial, which will be carried out at four research sites in the US.
As well as Stanford University, the other research sites include Salt Lake City, New York City, and Nova Southeastern University in Fort Lauderdale, Florida.
The trial will evaluate a combination of a low-dose CNS stimulant (methylphenidate - a generic version of Ritalin) co-administered with a CFS mitochondrial support formula.
The company said that the 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 where concomitantly administered methylphenidate can produce a positive effect on CFS symptoms.
When this treatment was previously administered to 15 prospectively recruited patients as a new therapy, it produced positive results that improved both fatigue and concentration disturbance symptoms as measured by the checklist individual strength (CIS).
Based on the positive results, the company is pursuing further investigation of this new therapy.
CIS is a validated research tool used to evaluate fatigue in patients with CFS, which is a debilitating disease that currently affects more than two million people in the US and has no FDA-approved treatments.