A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients

Exclusion Criteria

• •Subject discontinued from the preceding trial 243-05-001.
• •Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-05-001.
• •Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-05-001.
• •Subject had persistent hallucination or delusion during trial 243-05-001.
• •Subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
• •Subject has orthostatic hypotension at baseline.
• •Subject has a history of epilepsy, convulsion etc. during trial 243-05-001.
• •Subject has a complication of serious cardiac disorder.
• •Subject has arrhythmia and need to be treated with class 1a antiarrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 antiarrhythmic drugs (e.g. amiodarone, sotalol etc.).
• •Subject develops serious ECG abnormality at the baseline.
• •Subject has QTc-interval \>= 500 msec at the baseline or subject has an increase of QTc-interval \>= 60 msec from the baseline in the trial 243-05-001 and has a QTc-interval \> 470 msec in female or \> 450 msec in male at the baseline.
• •Subject had hypokalaemia in 243-05-001 study and not yet recovered.
• •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 the end of the period in trial 243-05-001.
• •Subject has BUN \>= 25 mg/dL or serum creatinine \>= 2.0 mg/dl at the end of the taper period in trial 243-05-001.
• •Subject has a history of allergic reaction to topical agents such as transdermal patch. Subject showed serious or extensive application site reactions beyond the application site in the 243-05-001 study.
• •Subject who plans pregnancy during the trial.
• •Subject has dementia.
• •Subject is unable to give consent.
• •Subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.