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Teleurstellende

resultaten

KPAX002 trial

 

 

 

 


 

 

 

In strijd met een hoopgevend persbericht zijn de effecten van KPAX002 teleurstellend te noemen.

 

KPAX002 is een combinatie van methylfenidaat hydrochloride (Ritalin), dat (extra) dopamine

vrijmaakt, en diverse supplementen om de werking van de mitochondria te stimuleren,

 

 

De (CIS) vermoeidheidsscore (minimum 20, maximum 140) nam in de KPAX groep af met 16,9,

maar ook in de placebo-groep nam de CIS F vermoeidheidsscore met 13,8 (bijna 10%) af.

 

Dat laatste toont eens te meer aan dat de effecten op objectieve maatstaven het meest relevant zijn.

 

 


 

 

 

KPAX002 as a treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): a prospective, randomized trial.

Int J Clin Exp Med 2018;11(3):2890-2900. ISSN:1940-5901/IJCEM0010510.

Montoya JG, Anderson JN, Adolphs DL, Bateman L, Klimas N, Levine SM, Garvert DW, Kaiser JD.

 

 

Mitochondrial dysfunction and a hypometabolic state are present in

patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

 

KPAX002 consists of low-dose methylphenidate hydrochloride to treat a hypometabolic state

combined with key micronutrients intended to broadly support mitochondrial function.

 

The objective of this study was to evaluate KPAX002 as a treatment for

fatigue and concentration disturbance symptoms in ME/CFS subjects.

 

This phase 2 randomized, double-blinded, placebo-controlled trial

was conducted at 4 sites in the United States.

 

A total of 135 subjects with ME/CFS

were randomly assigned to either KPAX002 (n=67) or placebo (n=68) for 12 weeks of treatment.

 

The primary endpoint was

change in the Checklist Individual Strength (CIS) total score from baseline to Week 12.

 

Secondary measurements included

visual analog scales for fatigue and concentration disturbance symptoms.

 

In the intent-to-treat population,

the mean reduction in the CIS total score from baseline to week 12

for the KPAX002 and placebo groups was -16.9 ( 23.52) and -13.8 ( 22.15), respectively

(95% confidence interval, -11.1, 4.0; P=0.359).

 

 

On the visual analog scale for fatigue,

the mean reduction from baseline to week 12 was -18.2 mm ( 25.05) and -11.1 mm ( 22.08)

for the KPAX002 and placebo groups, respectively (95% confidence interval, -11.5, 2.3; P=0.189).

 

The two groups demonstrating the most robust response to KPAX002

were subjects with more severe ME/CFS symptoms at baseline (P=0.086) and

subjects suffering from both fatigue and pain (P=0.057).

 

The incidence of adverse events was not statistically different between the two groups.

 

Treatment with KPAX002 resulted in

a reduction in fatigue and concentration disturbance symptoms in multiple analyses.

 

Two key subgroups of patients

whose response approached statistical significance were identified.

 

 

Keywords:

 

Chronic fatigue syndrome, myalgic encephalomyelitis, methylphenidate,

mitochondria, micronutrients, antioxidants

 

 

http://kpaxpharm.com/docs/research/Montoya-et-al-IJCEM-2018.pdf