a dose-finding study for spm 962 in advanced parkinson's disease patients

Conditions: Parkinson's Disease

Summary: the primary objective of this study is to investigate efficacy and safety of spm 962 in advanced parkinson's disease (pd) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of spm 962 within a range of 4.5 to 36.0 mg (12 weeks of dose titration/maintenance period). recommended maintenance dose range is also to be investigated with distribution of the maintenance dose and accumulated response rate of efficacy.


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 2) on and off phenomenon 3) delayed-on and/or no-on phenomenon 4) not well controlled with l-dopa due to adverse effect 5) weakening of l-dopa efficacy. exclusion criteria: * subject has previously participated in a trial with spm 962. * subject is on other dopamine agonist treatment within 28 days prior to the initial treatment. * subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test or baseline. * subject has orthostatic hypotension. * subject has a history of epilepsy, convulsion and other. * subject has a complication of serious cardiac disorder or has the history. * subject has arrhythmia and treated with class 1a antiarrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 antiarrhythmic drugs (e.g. amiodarone, sotalol etc.). * at screening and baseline, subject develops serious ecg abnormality. 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 has hypokalaemia. * 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. * subject has bun \>= 25 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 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. * subject is unable to give consent. * subject is participating in another trial of an investigational drug or done so within 24 weeks prior to the initial treatment. * investigator judges that subject is inappropriate as a study subject with other reasons.

Keywords: spm 962 rotigotine parkinson's disease concomitant use of l-dopa