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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.

Authors
  • Holodniy, Mark1
  • Kaiser, Jon D2
  • 1 Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA; Stanford University School of Medicine, Stanford, CA, USA.
  • 2 K-PAX Pharmaceuticals, Inc, Mill Valley, CA, USA; University of California San Francisco Medical School, San Francisco, CA, USA. Electronic address: [email protected]
Type
Published Article
Journal
Journal of psychiatric research
Publication Date
Nov 01, 2019
Volume
118
Pages
14–20
Identifiers
DOI: 10.1016/j.jpsychires.2019.08.003
PMID: 31446218
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

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. Published by Elsevier Ltd.

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