A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
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 safety of SPM 962 in advanced PD
      patients in a multi-center, open-label, non-controlled study following once-daily multiple
      transdermal doses of SPM962 within a range of 4.5 to 36.0 mg (maximum treatment period: 54
      weeks). Efficacy is also to be exploratory investigated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject completed the preceding trial 243-05-001.

        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.