id author title date pages extension mime words sentences flesch summary cache txt cord-286404-eggkqq3b Strayer, David R. Effect of disease duration in a randomized Phase III trial of rintatolimod, an immune modulator for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome 2020-10-29 .txt text/plain 5439 266 47 CONCLUSION/SIGNIFICANCE: Analysis of ETT from a Phase III trial has identified within the ITT population, a subset of ME/CFS patients with ≥2 fold increased exercise response to rintatolimod. In the AMP-516 Phase III clinical trial, patients with severe ME/CFS demonstrated significant improvement in the primary endpoint, exercise treadmill tolerance (ETT), compared to placebo controls following the twice weekly for 40 weeks systemic administration [12] of the selective TLR3 dsRNA agonist, rintatolimod (Ampligen 1 ) [10, 11]. Effect of ME/CFS duration in response to rintatolimod fewer patients and reduced statistical power compared to the ITT population (n = 208), the placebo-adjusted mean increase in ETT (Δ = 23.6) within the Target Subset (n = 75) was statistically significant. This post-hoc analysis of the successful AMP-516 double-blind, placebo-controlled, randomized, Phase III trial has identified a subgroup of patients defined primarily by the length of ME/CFS symptoms (2-8 years) with an increased likelihood of a clinically beneficial response to rintatolimod. ./cache/cord-286404-eggkqq3b.txt ./txt/cord-286404-eggkqq3b.txt