a placebo- and ropinirole-controlled study for spm 962 in advanced parkinson's disease patients

Conditions: Parkinson's Disease

Summary: * to demonstrate the non-inferiority of spm 962 to ropinirole in terms of efficacy in order to confirm clinical value of spm 962. * to demonstrate the superiority of spm 962 to placebo in terms of efficacy. * to investigate the tolerability and safety of spm 962 up to 36.0 mg/day.


Eligibility criteria:
inclusion criteria: * subject diagnosed as having parkinson's disease in accordance with "diagnostic criteria established by the research committee of mhlw-specified intractable neurodegenerative diseases (1995)". * subject is 30 and more and less than 80 years of age at the time of informed consent. * hoehn \& yahr stage 2-4 (on time). * total updrs part 3 score is over 10 at screening test (on time). * subject is on a stable dose of l-dopa with no change in daily dose or dosing regimen for at least 28 days prior to the initial treatment of spm 962. * subject has any of the following problematic symptoms; 1) wearing off phenomenon (including frozen gait at off time and dystonia at off time) 2) on and off phenomenon 3) delayed-on and/or no-on phenomenon 4) dyskinesia 5) not well controlled with l-dopa. exclusion criteria: * subject who has previously participated in a clinical trial of spm962 and taken the investigational product (ip). * subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test or baseline. * subject whose sbp declines by at least 30 mmhg from supine to standing position based on the orthostatic hypotension assessment, or subject who develops orthostatic hypotension at baseline. * subject has a history of epilepsy, convulsion and other. * subject who has complications or a history of serious cardiac diseases or arrhythmia (eg, congestive heart failure of class 3 or 4 in the nyha classification, second or third degree atrioventricular block, complete left bundle branch block, sick sinus syndrome, ventricular fibrillation, myocardial infarction within 12 months prior to the screening test, or a complication of angina pectoris). * subjects has qtc-interval \>450 msec twice at screening. subject has a the average qtc-interval from two ecgs \>450 msec in males and \>470 msec in females at baseline. * subject has congenital long qt syndrome. * subject whose serum potassium level is \< 3.5meq/l at the screening test. * subject has a total bilirubin \>= 3.0 mg/dl or ast(got) or alt(gpt) greater than 2.5 times of the upper limit of the reference range (or \>= 100 iu/l) at screening test, or suffers complications of active phase of chronic hepatitis or liver cirrhosis. * subject has bun \>= 30 mg/dl or serum creatinine \>= 2.0 mg/dl at screening test. * subject has a history of allergic reaction to topical agents such as transdermal patch. * subject has a history of known intolerance/hypersensitivity to ropinirole and/or adverse drug reactions that prevent subject from receiving treatment. * subject is pregnant or nursing or woman who plans pregnancy during the trial. * subject is receiving therapy with prohibited drug specified in the study protocol. * subject has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant. * subject has dementia, including dlb and pdd (mmse score \<= 24 at screening). * subject who has a complication or history of malignant neoplastic disease, or received treatment for the disease within 12 months prior to the screening test. * subject is unable to give consent. * subject who is unable to properly record information in a diary. * subject is participating in another trial of ips or received other ips within 12 weeks prior to commencement of study treatment. * investigator judges that subject is inappropriate as a study subject with other reasons.