NCT01628926已完成3 期
A Double-Blind, 3-Arm, Parallel Group, Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 420
- 主要终点
- Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score
研究概览
简要总结
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
SPM 962
Experimental
SPM 962 transdermal patch
干预措施: SPM 962 (Drug)
Ropinirole
Active Comparator
Ropinirole tablet
干预措施: Ropinirole (Drug)
Placebo
Placebo Comparator
SPM962 placebo patch and Ropinirole placebo tab
干预措施: Placebo (Drug)
结局指标
主要结局
Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score
时间窗: baseline, 16 weeks after dosing
Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 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.
次要结局
- Dystonia (at an Early Hour)(Baseline, 16 weeks after dosing)
- Dystonia (in the Daytime)(Baseline, 16 weeks after dosing)
- UPDRS Part 3 Sum Score(baseline, 8 and 10 weeks after dosing)
- UPDRS Part 2 Sum Score(Baseline, 16 weeks after dosing)
- Off Time(Baseline, 16 weeks after dosing)
- Parkinson's Disease Sleep Scale-2 (PDSS-2)(Baseline, 16 weeks after dosing)
- On Time(Baseline, 16 weeks after dosing)
- On Time Without Dyskinesia Disturbing Daily Activities(Baseline, 16 weeks after dosing)
- On Time With Dyskinesia Disturbing Daily Activities(Baseline, 16 weeks after dosing)
- Effective Rate in UPDRS Part 3 Sum Score(Baseline, 16 weeks after dosing)
- Effective Rate in UPDRS Part 2 Sum Score(Baseline, 16 weeks after dosing)
- Effective Rate in Off Time(Baseline, 16 weeks after dosing)
- Clinical Global Impression (CGI)(Baseline, 16 weeks after dosing)
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