Treatment for Gulf War Illness (GWI) with KPAX002 (methylphenidate hydrochloride + GWI nutrient formula) - Holodniy, Kaiser Aug 2019

[Sly Saint]

Full title
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 (revision 2)

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.

https://www.sciencedirect.com/science/article/abs/pii/S0022395619302651

(not available on Sci-hub yet)
see also similar trial done on ME/CFS
https://www.s4me.info/threads/kpax0...ive-randomized-trial-2018-montoya-et-al.3410/

 

[adambeyoncelowe]

Does anyone have a copy of the GWI Symptoms Assessment Tool?

 

[Snow Leopard]

Open label, sigh...

 

[beverlyhills]

There's this new drug called cheese, it gets you high. it's tylenol and heroin. so basically... heroin.

 

[NelliePledge]

Wasn’t KPAX a planet Kevin Spaceys character said he came from. Can’t remember what film. Seems a bizarre choice for a name for an alleged medication

 

[Hutan]

Here's the thread on KPAX for CFS. Null result.
If at first you don't succeed (at getting some 'science' to prop up your marketing campaign) try again.

 

[Forbin]

Wasn’t KPAX a planet Kevin Spaceys character said he came from. Can’t remember what film. Seems a bizarre choice for a name for an alleged medication

Not surprisingly, the film, which was released in 2001, was called... "K-PAX." https://en.wikipedia.org/wiki/K-PAX_(film)

 

[Hutan]

The film is about a psychiatric patient who claims to be an alien from the planet K-PAX. During his treatment, the patient demonstrates an outlook on life that ultimately proves inspirational for his fellow patients and especially for his psychiatrist.

Oh dear.

 

[Sly Saint]

scihub link to full paper

https://sci-hub.tw/10.1016/j.jpsychires.2019.08.003

 

[Milo]

Drop out rate of 33%