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

Otsuka

Status and phase

Completed

Phase 3

Conditions

Parkinson's Disease

Treatments

Drug: SPM 962

Study type

Interventional

Funder types

Industry

Identifiers

NCT01631825

243-08-002

Details and patient eligibility

About

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.

Enrollment

321 patients

Sex

All

Volunteers

No Healthy Volunteers

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.