A Dose-ranging Study for SPM 962 in Parkinson's Disease Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: SPM 962
Intervention description: SPM 962 transdermal patch once a daily up to 36.0 mg/day
Intervention MeSH terms: Rotigotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 30 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: SPM 962; rotigotine; Parkinson's disease

Summary:

      The primary objective of this trial is to establish the maximum maintenance dose of SPM 962
      in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by
      conducting safety evaluation of each patient following once-daily transdermal doses of SPM
      962 within a range of 4.5 to 36.0 mg. (The administration period will consist of a standard
      8-week dose-titration period, 4-week dose-maintenance period, and a dose de-escalation
      period) Exploratory evaluation of each patient's maintenance dose will also be conducted with
      attention to patient safety. The relationship of pharmacokinetics, safety, and efficacy will
      also be examined.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For subject with early and advanced Parkinson's disease

               -  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.

               -  Gender and inpatient-outpatient status are not specified.

          -  For subject with early Parkinson's disease

               -  Hoehn & Yahr stage 3 or less.

               -  Subject who has not taken L-dopa within 28 days prior to initial administration
                  of SPM 962.

          -  For subject with dvanced Parkinson's disease

               -  Hoehn & Yahr stage 2-4.

               -  Subject is on a stable dose of L-dopa with no change in daily dose or dosing
                  regimen for at least 7 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) Not well controlled with L-dopa due to adverse effect
                  4) Weakening of L-dopa efficacy.

        Exclusion Criteria:

          -  Subject is on other dopamine agonist treatment within 7 days prior to the initial
             treatment. Subject is on cabergoline treatment within 14 days prior to the initial
             treatment.

          -  Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation,
             delirium, abnormal behavior.

          -  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 at screening. Subject has QTc-interval >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).

          -  Subject has BUN >= 25 mg/dL or serum creatinine >= 2.0 mg/dl.

          -  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
             6 months prior to the initial treatment.

          -  Investigator judges that subject is inappropriate as a study subject with other
             reasons.