K-PAX Pharmaceuticals (Mill Valley, CA) was awarded a DoD Innovative Treatment Evaluation Award (ITEA) by the CDMRP to conduct a Phase 2 open-label trial of KPAX002 - GWI Nutrient Formula (mitochondrial modulators) paired with low dose methylphenidate hydrochloride (Ritalin®) - to evaluate its potential as a treatment for Veterans with Gulf War Illness (GWI).
KPAX002 is made up of two currently available components: 1) low dose Ritalin 2) K-PAX Immune: a micronutrient supplement that supports mitochondrial function across all bodily systems.
The trial, conducted at the Palo Alto VA Health Care System from 2015-2017, examined 15 veterans with a diagnosis of Gulf War Illness.
The results of the trial showed that KPAX002 produced a mean 25% reduction in overall GWI symptoms. This result was shown to be statistically significant using multiple analytical methods. There were also significant improvements in other GWI symptoms including fatigue, alertness, pain and sleep.
The full study publication can be downloaded (until 10/11/19) at: https://kpaxpharm.com/research/