A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

• To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in order to confirm clinical value of SPM 962.

• To demonstrate the superiority of SPM 962 to placebo in terms of efficacy.

• To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.

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

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Ropinirole

Criteria

Inclusion Criteria:

• Subject diagnosed as having Parkinson's disease in accordance with "Diagnostic Criteria established by the Research Committee of MHLW-specified Intractable Neurodegenerative Diseases (1995)".

• Subject is 30 and more and less than 80 years of age at the time of informed consent.

• Hoehn & Yahr stage 2-4 (on time).

• Total UPDRS Part 3 score is over 10 at screening test (on time).

• Subject is on a stable dose of L-dopa with no change in daily dose or dosing regimen for at least 28 days prior to the initial treatment of SPM 962.

• Subject has any of the following problematic symptoms; 1) Wearing off phenomenon (including frozen gait at off time and dystonia at off time) 2) On and off phenomenon 3) Delayed-on and/or No-on phenomenon 4) Dyskinesia 5) Not well controlled with L-dopa.

Exclusion Criteria:

• Subject who has previously participated in a clinical trial of SPM962 and taken the investigational product (IP).

• Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test or baseline.

• Subject whose SBP declines by at least 30 mmHg from supine to standing position based on the orthostatic hypotension assessment, or subject who develops orthostatic hypotension at baseline.

• Subject has a history of epilepsy, convulsion and other.

• Subject who has complications or a history of serious cardiac diseases or arrhythmia (eg, congestive heart failure of class 3 or 4 in the NYHA classification, second or third degree atrioventricular block, complete left bundle branch block, sick sinus syndrome, ventricular fibrillation, myocardial infarction within 12 months prior to the screening test, or a complication of angina pectoris).

• Subjects has QTc-interval >450 msec twice at screening. Subject has a the average QTc-interval from two ECGs >450 msec in males and >470 msec in females at baseline.

• Subject has congenital long QT syndrome.

• Subject whose serum potassium level is < 3.5mEq/L at the screening test.

• 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 screening test, or suffers complications of active phase of chronic hepatitis or liver cirrhosis.

• Subject has BUN >= 30 mg/dL or serum creatinine >= 2.0 mg/dl at screening test.

• Subject has a history of allergic reaction to topical agents such as transdermal patch.

• Subject has a history of known intolerance/hypersensitivity to ropinirole and/or adverse drug reactions that prevent subject from receiving treatment.

• Subject is pregnant or nursing or woman who plans pregnancy during the trial.

• Subject is receiving therapy with prohibited drug specified in the study protocol.

• Subject has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant.

• Subject has dementia, including DLB and PDD (MMSE score <= 24 at screening).

• Subject who has a complication or history of malignant neoplastic disease, or received treatment for the disease within 12 months prior to the screening test.

• Subject is unable to give consent.

• Subject who is unable to properly record information in a diary.

• Subject is participating in another trial of IPs or received other IPs within 12 weeks prior to commencement of study treatment.

• Investigator judges that subject is inappropriate as a study subject with other reasons.