Various approaches have been studied in treating Chronic Fatigue Syndrome (CFS), including the use of stimulant drugs and micronutrients. However, they had not been previously studied in combination.
In the July 2015 issue of the International Journal of Clinical and Experimental Medicine (IJCEM), Dr. Jon Kaiser published a proof of concept trial which showed that a low dose stimulant combined with a proprietary formula of mitochondrial support nutrients was able to significantly improve fatigue and concentration disturbance symptoms in greater than 50% of CFS patients. Dr. Kaiser is a CFS clinician and researcher and also the Chief Medical Officer of K-PAX Pharmaceuticals.
Methylphenidate (commonly known as Ritalin®) was the stimulant drug used as part of the fixed-dose combination in this trial. A previous trial using low-dose methylphenidate alone showed somewhat promising results. Kaiser believed that by combining the methylphenidate with mitochondrial support nutrients, improved safety and efficacy could be achieved.
Since there is a growing body of evidence that people with ME/CFS have some degree of mitochondrial dysfunction, Dr. Kaiser initially provided this treatment to patients in his clinic suffering from CFS. The treatment produced exciting results. In some cases, patients who had been disabled by their CFS symptoms for many years experienced a vast improvement, allowing them to return to work within a few months of starting the treatment.
These positive clinical findings set the stage for a 12-week proof of concept trial utilizing this innovative combination treatment.
Fifteen patients diagnosed with CFS by the 1994 Fukuda criteria were recruited and treated with KPAX002 (methylphenidate and mitochondrial support nutrients). Fatigue and concentration disturbance symptoms were measured at baseline, 4 weeks, and 12 weeks using two clinically validated tools: the Checklist Individual Strength (CIS) and Visual Analog Scale (VAS).
Treatment with KPAX002 was well tolerated and significantly improved fatigue and concentration disturbance symptoms in greater than 50% of patients with CFS. Results were published in the July 2015 issue of International Journal of Clinical and Experimental Medicine. Further investigations are planned.
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