Study Design Rationale Sample Clauses

Study Design Rationale. The study described here is a Phase 2 proof-of-concept investigation of the efficacy of ricolinostat for the treatment of diabetic neuropathic pain. As noted above, ricolinostat is a potent inhibitor of HDAC6 enzyme activity and represents a promising novel approach to the treatment of diabetic neuropathic pain. As described above and in the Investigator’s Brochure, preclinical data from animal models suggest that ricolinostat may offer advantages over currently available therapies with respect to magnitude of effect, duration of effect, and/or tolerability. Because pain is measured subjectively, it can be subject to expectation bias or other non-specific effects, and in order to accurately assess the efficacy of interventions, it is important to control for this. For this reason, this study is designed as double-blind and placebo-controlled. The use of placebo rather than active comparator is required to provide a definitive understanding of whether observed improvement is or is not treatment-specific, and is justified on scientific and ethical grounds, as 1) there is no convincing evidence that the active treatments currently available to patients change the course of the disease, and thus patients are not put at risk for disease worsening or long-term harm by not administering currently available active treatments for limited periods; 2) rescue medication for acute episodes of pain is permitted in this protocol to ensure that patients are not at risk for excessive discomfort; and 3) per protocol, one medication that patients have been taking to treat their pain for at least 3 months at the time of Screening can be continued during the study provided the regimen has been stable and is expected to remain stable during the study.‌‌‌‌‌‌
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