A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: SPM 962; Placebo
Intervention description: SPM 962 transdermal patch once a daily up to 36.0 mg/day; Placebo transdermal patch
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 174.0
Sex: All
Minimum age: 30 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: SPM 962; rotigotine; Parkinson's disease; concomitant use of L-dopa

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.