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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: Placebo; Drug: SPM 962; Drug: Ropinirole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01628926

243-08-001

JapicCTI-090888 (Other Identifier)

Details and patient eligibility

About

• 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.

Enrollment: 420 patients

Sex: All

Ages: 30 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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420 participants in 3 patient groups, including a placebo group

SPM 962

Experimental group

Description:

SPM 962 transdermal patch

Treatment:

Drug: SPM 962

Ropinirole

Active Comparator group

Description:

Ropinirole tablet

Treatment:

Drug: Ropinirole

Placebo

Placebo Comparator group

Description:

SPM962 placebo patch and Ropinirole placebo tab

Treatment:

Drug: Placebo