Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500 (6500-004)

INTERVENTION: Intervention name : KW‐6500 Dosage And administration of the intervention : Twelve weeks subcutaneous injection of 1 to 6 mg for the OFF state CONDITION: Parkinson's Disease PRIMARY OUTCOME: The raw score change in UPDRS part III score at the double blind period SECONDARY OUTCOME: The percent score change in UPDRS Part III score and response ratio at the double blind period INCLUSION CRITERIA: ‐ Patients who have given written informed consent ‐ Patients who have Parkinson's disease ‐ Patients who have been on a stable regimen of levodopa plus at least one other antiparkinsonian agent and who have OFF state ‐ Patients who meet stage 4 or 5 while in the OFF state and stage 0 to 3 while in the ON state on the Modified Hoehn and Yahr Scale ‐ Patients who have experienced a 30% or more improvement in Unified Parkinson's Disease Rating Scale (UPDRS) part III score when tested for responsiveness to levodopa during the baseline period ‐ Patients who have at least one OFF state per day ‐ Patients who can understand the expression of OFF state, ON state, and dyskinesia ‐ Patients or their families have a desire for self‐injection of KW‐6500