A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients

Otsuka Pharmaceutical Co., Ltd.174 enrolled

Overview

The primary objective of this study is to investigate efficacy and safety of SPM 962 in advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also to be investigated with distribution of the maintenance dose and accumulated response rate of efficacy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

174

Conditions

Parkinson's Disease

Interventions

SPM 962DRUG

SPM 962 transdermal patch once a daily up to 36.0 mg/day

PlaceboDRUG

Placebo transdermal patch

Eligibility

Sex: ALLMin age: 30 YearsMax age: 79 Years

Medical Language ↔ Plain English

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 2) On and off phenomenon 3) Delayed-on and/or No-on phenomenon 4) Not well controlled with L-dopa due to adverse effect 5) Weakening of L-dopa efficacy. Exclusion Criteria: * Subject has previously participated in a trial with SPM 962. * Subject is on other dopamine agonist treatment within 28 days prior to the initial treatment. * Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test or baseline. * Subject has orthostatic hypotension. * Subject has a history of epilepsy, convulsion and other. * Subject has a complication of serious cardiac disorder or has the history. * Subject has arrhythmia and treated with class 1a antiarrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 antiarrhythmic drugs (e.g. amiodarone, sotalol etc.). * At screening and baseline, subject develops serious ECG abnormality. 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 has hypokalaemia. * 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. * Subject has BUN \>= 25 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 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. * Subject is unable to give consent. * Subject is participating in another trial of an investigational drug or done so within 24 weeks prior to the initial treatment. * Investigator judges that subject is inappropriate as a study subject with other reasons.

Locations (7)

Unnamed facility

Chubu Region, Japan

Unnamed facility

Hokkaido Region, Japan

Unnamed facility

Kanto Region, Japan

Unnamed facility

Kinki Region, Japan

Unnamed facility

Kyushu Region, Japan

Outcomes

Primary Outcomes

Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score

Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing. UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.

Time frame: baseline, 12 weeks after dosing

Secondary Outcomes

UPDRS Part 2 Sum Score (Average Score of on State and Off State)

Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 12 weeks after dosing. Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average score of on state and off state) at 12 weeks after dosing. UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.

Time frame: baseline, 12 weeks after dosing

Off Time

Mean change (LOCF) from baseline in off time at 12 weeks after dosing.

Time frame: baseline, 12 weeks after dosing

Effective Rate in UPDRS Part 3 Sum Score

Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score at 12 weeks after dosing.

Time frame: Baseline, 12 weeks after dosing

UPDRS Part 1 Sum Score

Mean change (LOCF) from baseline in UPDRS Part 1 sum score at 12 weeks after dosing. UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.

Data from ClinicalTrials.gov

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