A phase 2 double-blinded, placebo-controlled trial of KPAX002 as a treatment for ME/CFS (n=128)

The Synergy Trial was a phase 2 clinical trial designed to further investigate the safety and efficacy of KPAX002 for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) .  KPAX002 is a combination of a low-dose CNS stimulant plus a mitochondrial modulator designed to lessen fatigue and concentration disturbance symptoms in patients with ME/CFS.

Treatment utilizing KPAX002 lessened overall CFS symptoms and concentration disturbances (brain fog) in a majority of the study subjects. Our findings included:

- 36% of the patients taking the KPAX002 treatment had a >20% reduction in overall ME/CFS symptoms after 28 days.

- Patients taking KPAX002 had substantially greater improvement in all four CIS subscrores than those taking placebo after 12 weeks.

- More symptomatic patients at baseline experienced double the improvement as patients beginning the trial with less severe symptoms.

Treatment with KPAX002 was demonstrated to be safe and well tolerated in patients with ME/CFS.