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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

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.