A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: N 0437; Rotigotine

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.