Treatment for Gulf War Illness (GWI) with KPAX002 (methylphenidate hydrochloride + GWI nutrient formula) in subjects meeting the Kansas case definition: A prospective, open-label trial

• Published in: Journal of psychiatric research Vol. 118; pp. 14 - 20
• Main Authors: Holodniy, Mark, Kaiser, Jon D.
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.11.2019
• Subjects: Antioxidants; Chronic fatigue syndrome; Gulf war illness; Methylphenidate; Micronutrients; Mitochondria; Stimulants; Veterans; Antioxidants; Micronutrients; Mitochondria; Stimulants; Veterans; Gulf war illness; Chronic fatigue syndrome; Methylphenidate
• ISSN: 0022-3956; 1879-1379; 1879-1379
• DOI: 10.1016/j.jpsychires.2019.08.003

This study tested the safety, tolerability, and efficacy of KPAX002—a combination of methylphenidate hydrochloride plus a micronutrient formula designed to support mitochondrial function—as a treatment for Gulf War Illness (GWI). This open-label trial enrolled 17 subjects meeting the Kansas case definition for GWI. Of the 17 subjects enrolled, 15 qualified for the Intent-to-Treat (ITT) population with 10 subjects completing the trial per protocol. All analyses were on the ITT population. At 12 weeks, subjects taking KPAX002 experienced a mean 25% reduction in their overall GWI symptoms severity as measured by the GWI Symptoms Assessment Tool (SAT) (p < 0.001). Visual analog scale scores were also significantly reduced for fatigue (p = 0.019), cognitive symptoms (p = 0.006), sleep problems (p = 0.026), and pain (p = 0.05). Twelve weeks of KPAX002 administration resulted in a significant improvement in GWI symptoms with an acceptable side effect profile. A larger randomized, double-blinded, placebo-controlled trial is necessary to determine if the observed benefit can be replicated.