A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa

INTERVENTION: Intervention name : SPM 962 Dosage And administration of the intervention : SPM 962: transdermal application, 1 time per day. Initial dose:4.5mg/day, weekly increment of 4.5mg/day, maximal maintenance dose : 36.0mg/day. Placebo of ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day Control intervention name : Ropinirole Dosage And administration of the control intervention : placebo SPM 962: transdermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Ropinirole: oral application 3 times per day. Initial dose:0.75mg/day, weekly increment of 0.75mg/day (up to 3.0mg/day), then 1.5mg/day (up to 15.0mg/day), maximal maintenance dose 15.0 mg/day. Control intervention name : Placebo Dosage And administration of the control intervention : placebo SPM 962: transermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Placebo ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day. CONDITION: Parkinson's Disease Treated Concomitantly with L‐dopa PRIMARY OUTCOME: Change from the baseline to the end of the dose‐titration/maintenance period inUPDRS Part III total score ( "on" time) SECONDARY OUTCOME: 1) Change from the baseline to Week 8 (LOCF) and Week 10 (LOCF) in dose titration/maintenance period in UPDRS Part III ("on" time) sum score ; 2) UPDRS Part II (average "on" and "off" time) sum score; 3) Off time ; 4) On time ; 5) On time when troublesome dyskinesia is absent; 6) On time with troublesome dyskinesia is present; 7) Responder rate of UPDRS Part III ("on" time) sum score; 8) Responder rate of UPDRS Part II (average of "on" and "off" time); 9) Responder rate of "off" time; 10) CGI (Severity of disease); 11) Early morning dystonia; 12) Daytime dystonia INCLUSION CRITERIA: 1. Patients diagnosed as having PD in accordance with the "Diagnostic Criteria established by the Research Committee of MHLW‐specified Intractable Neurodegenerative Diseases (1995)" 2. Patients aged >30 years and <80 years at the time of informed consent 3. Patients with a modified Hoehn & Yahr scale score of 2 to 4 ("on" time) 4. Patients with a UPDRS Part III total score of >10 at screening ("on" time) 5. Patients who have received a fixed dose of L‐dopa (ie, no change in daily dose or dosing regimen) for at least 28 days prior to the baseline (including a day for initial treatment) 6. Patients with any of the following problematic symptoms : a. Wearing off phenomena (including frozen gait at "off" time and dystonia at "off" time) b. On‐off phenomenon c. Delayed on and/or no‐on phenomena d. Dyskinesia e. Insufficient efficacy of L‐dopa