A Phase 3 Study of TAS-205 in Patients With Duchenne Muscular Dystrophy（REACH-DMD）

Exclusion Criteria

• •Patients who have serious concomitant drug hypersensitivity or medical history
• •Patients who have used cyclooxygenase-1 (COX-1) or COX-2 inhibitors, or nonsteroidal anti-inflammatory drugs (NSAIDs) during 7 days before the measurement of time to rise from the floor in the screening period
• •Patients who have incurred an injury (trauma/damage) that may affect muscle strength or motor function within 3 months before enrollment or who have an uncured injury (trauma/damage) that may affect muscle strength or motor function at the enrollment
• •Patients who have received gene-/cell-based therapy or stop-codon readthrough therapy with antisense oligonucleotides
• •Patients who have participated in another clinical trial and received a study drug within 90 days before study drug administration in the present study
• •Patients with a left ventricular ejection fraction (EF) of \<40% or left ventricular fractional shortening (FS) of \<25% on the cardiac ultrasonography (echocardiography) at observation period
• •\[Non-ambulatory Cohort\]
• •Patients with severe cardiac disease (including a history of pacemaker surgery)
• •Patients with left ventricular EF \<40% on echocardiography within 14 days prior to enrollment
• •Patients with %FVC less than 40% within 14 days prior to enrollment
• •Patients with respiratory diseases such as asthma, bronchitis, COPD, bronchiectasis, emphysema, pneumonia, etc. (including chronic use of beta2 agonists, inhaled steroids, sympathomimetics, anticholinergic agents, etc.)
• •Patients on continuous ventilator use (excluding use while sleeping)
• •Patients who have undergone surgery within 180 days prior to enrollment that may affect muscle strength or exercise, pulmonary function, or cardiac function, or are planning such surgery during the study period
• •Injury (trauma/injury) within 90 days prior to enrollment that may affect muscle strength or motor, pulmonary, or cardiac function, or that has not healed at the time of enrollment
• •Patients who are judged by the principal investigator or subinvestigator to have brain dysfunction such as intellectual disability, autistic tendencies, and attention deficit hyperactivity disorder that would interfere with the performance of efficacy and safety evaluation
• •Patients with systemic allergic or chronic inflammatory diseases that may interfere with the interpretation of efficacy or safety data (except allergic rhinitis, localized or mild atopic dermatitis, eczema, etc.)
• •Patients enrolled in Treatment Phase Part A of this study's Ambulatory Cohort