Long Term Follow-up 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 CONDITION: Spinal and Bulbar Muscular Atrophy (SBMA) PRIMARY OUTCOME: Pharyngeal barium residue (%); in videofluorography SECONDARY OUTCOME: Clinical scores (ALSFRS‐R, QMG Score, 6‐minute walk); QOL (ALSAQ‐5); serum creatine kinase (CK) INCLUSION CRITERIA: 1) Patients who finished double‐blind placebo‐controlled phase III clinical trial of TAP‐144‐SR (3M) in patients with spinal and bulbar muscular atrophy (SBMA). 2) Patients who have no desire to father a child. 3) Patients with written informed consent. 4) Patients who are capable of ambulatory hospital visits.