A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients

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.