A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: SPM 962; Ropinirole; Placebo
Intervention description: SPM 962 transdermal patch once a daily up to 36.0 mg/day; Ropinirole oral administration TID up to 15.0 mg/day; SPM962-placebo patch and Ropinirole-placebo tab
Intervention MeSH terms: Ropinirole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 420.0
Sex: All
Minimum age: 30 Years
Maximum age: 79 Years
Healthy volunteers: No

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.