A Placebo-controlled Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 174
- 主要终点
- Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score
研究概览
简要总结
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.
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 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.
排除标准
- •Subject has previously participated in a trial with SPM
- •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.
研究组 & 干预措施
SPM 962
SPM 962 transdermal patch
干预措施: SPM 962 (Drug)
Placebo
Placebo transdermal patch
干预措施: Placebo (Drug)
结局指标
主要结局
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score
时间窗: baseline, 12 weeks after dosing
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.
次要结局
- UPDRS Part 2 Sum Score (Average Score of on State and Off State)(baseline, 12 weeks after dosing)
- Off Time(baseline, 12 weeks after dosing)
- Effective Rate in UPDRS Part 3 Sum Score(Baseline, 12 weeks after dosing)
- UPDRS Part 1 Sum Score(Baseline, 12 weeks after dosing)
- Effective Rate in Off Time(Baseline, 12 weeks after dosing.)
- UPDRS Part 2 Sum Score (on State)(Baseline, 12 weeks after dosing)
- UPDRS Part 2 Sum Score (Off State)(Baseline, 12 weeks after dosing)
- UPDRS Part 4 Sum Score(Baseline, 12 weeks after dosing)
- Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score(Baseline, 12 weeks after dosing)
- Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average Score of on State and Off State), UPDRS Part 3 Sum Score, and UPDRS Part 4 Sum Score.(Baseline, 12 weeks after dosing)
- The Modified Hoehn & Yahr Severity of Illness(Baseline, 12 weeks after dosing)