A Long-Term Extension Trial From 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
Intervention MeSH terms: Rotigotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 321.0
Sex: All
Healthy volunteers: No
Keywords: SPM 962; rotigotine; Parkinson's disease; concomitant use of L-dopa

Summary:

      -  To investigate the safety of once-daily repeated transdermal administration of SPM 962
           within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's
           disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label
           uncontrolled study.

        -  To investigate efficacy of SPM 962 in an exploratory manner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject completed the preceding trial 243-08-001.

        Exclusion Criteria:

          -  Subject discontinued from the preceding trial 243-08-001.

          -  Subject had a serious adverse event which association with the investigational drug
             was not ruled out during trial 243-08-001.

          -  Subject has a persistent serious adverse event at the baseline, which was observed and
             association with the investigational drug was ruled out during trial 243-08-001.

          -  Subject had persistent confusion, hallucination, delusion or excitation during trial
             243-08-001.

          -  Subject has abnormal behavior such as obsessive-compulsive disorder and delusion in
             243-08-001 study.

          -  Subject showed serious or extensive application site reactions beyond the application
             site in the 243-08-001 study.

          -  Subject has orthostatic hypotension or a systolic blood pressure (SBP) <= 100 mmHg and
             has a decrease of SBP from spine to standing position >= 30 mmHg at baseline.

          -  Subject has a history of epilepsy, convulsion etc. during trial 243-08-001.

          -  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 243-08-001 and has a
             QTc-interval > 470 msec in female or > 450 msec in male at the baseline.

          -  Subject had a serum potassium level < 3.5 mEq/L at the end of the taper period in
             trial 243-08-001.

          -  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 243-08-001.

          -  Subject had BUN >= 30 mg/dL or serum creatinine >= 2.0 mg/dl at the end of the taper
             period in trial 243-08-001.

          -  Subject who plans pregnancy during the trial.

          -  Subject is unable to give consent.

          -  Subject is judged to be inappropriate for this trial by the investigator for the
             reasons other than above.