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Daiichi Sankyo reported mixed results from the Phase III NEUCOURSE and ALDAY clinical trials with its oral pain management candidate, mirogabalin. The 14-week placebo-controlled NEUCOURSE study in Asian patients with post-herpetic neuralgia met its primary endpoint, and demonstrated that treatment using one of two doses of mirogabalin twice daily resulted in statistically significant reductions in the weekly average daily pain score (ADPS). The NEUCOURSE study involved 765 patients aged 20 years and older in Japan, Taiwan, Korea, Singapore, Malaysia and Thailand. The double-blind phase of the study was followed by a one-year, open-label extension. In contrast, three 13-week ALDAY trials assessing mirogabalin in the treatment of pain associated with fibromyalgia failed to meet their primary efficacy endpoint of statistically significant reductions from baseline in the weekly average of worst daily pain score. The three identical global ALDAY studies evaluated mirogabalin in over 3,600 patients aged 18 years and ...NEXT ARTICLE
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g...