Double-blind Placebo-controlled Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)

INTERVENTION: TAP‐144‐SR(3M) 11.25mg subcutaneous injection every 12 weeks Placebo subcutaneous injection every 12 weeks CONDITION: Spinal and Bulbar Muscular Atrophy(SBMA) PRIMARY OUTCOME: Pharyngeal barium residue (%); in videofluorography SECONDARY OUTCOME: Frequency of anti‐poly Q staining in Scrotal Skin ; Clinical scores (ALSFRS‐R, QMG Score, 6‐minute walk); QOL (ALSAQ‐5); serum creatine kinase (CK); parameters in videofluorography INCLUSION CRITERIA: 1) Clinically and/or genetically confirmed SBMA male patients in Japan who have more than one symptoms including muscle weakness, muscle atrophy, bulbar palsy and hand tremor. 2) Patients whose repeat number of CAG in androgen receptor gene is more than 38 in screening gene analysis. 3) Patients who are age 30 to 70 year‐old at the time of informed consent. 4) Patients who have no desire to father a child. 5) Patients whose liver function test and renal function test are within below limits. AST (GOT) smaller than 4.0 X upper limit of normal ALT (GPT) smaller than 4.0 X upper limit of normal Creatinine smaller than 1.5 X upper limit of normal 6) Patients who are capable of standing for 6 min with or without cane. 7) Patients who are capable of undergoing in hospital examinations at 0, 24th, 48th week and the time of quitting the trial. 8) Patients who are capable of ambulatory hospital visits. 9) Patients with written informed consen