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

Otsuka

Status and phase

Completed

Phase 2

Conditions

Parkinson's Disease

Treatments

Drug: SPM 962

Study type

Interventional

Funder types

Industry

Identifiers

NCT01631812

243-06-001

Details and patient eligibility

About

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.

Enrollment

130 patients

Sex

All

Volunteers

No Healthy Volunteers

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.