A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3
研究概览
简要总结
To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a multi-center, placebo-controlled, double-blind study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose titration/maintenance period)
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 years < > 80 years at the time of informed consent
- •Hoehn & Yahr stage 1- 3
- •Total of each sum score of UPDRS Part 2 and 3 is over 10 at screening test
排除标准
- •Subject has previously participated in a trial with SPM 962
- •Subject is on L-dopa treatment for total of over 6 months at the time of informed consent
- •Subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test and baseline
- •Subject has orthostatic hypotension
- •Subject has a history of epilepsy, convulsion and other
- •Subject has a complication of serious cardiac disorder/arrhythmia or has the history
- •Subject has arrhythmia and treated with class 1a anti-arrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 anti-arrhythmic drugs (e.g. amiodarone, sotalol etc.)
- •Subject has serious ECG abnormal at screening i.e.; 1) Subject has more than 450 msec of QTc values both in two measurements at screening test 2) Subject has more than 470 msec for females and more than 450 msec for males of mean QTc values of two measurements at baseline
- •Subject has congenital long QT syndrome
- •Subject has serum potassium of less than 3.5 mEq/L at screening test.
- •Subject has total bilirubin of 3.0 mg/dL and above or AST(GOT), ALT(GPT) greater than 2.5 times (or 100 IU/L and above) of the clinical laboratory's upper limit of the reference range at screening test
- •Subject has 30 mg/dL and above of BUN or 2.0 mg/dL and above of serum creatinine at screening test
- •Subject has a history of allergy to topical medicine, e.g. transdermal patch
- •Subject is pregnant, nursing, or is child bearing potential while 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 12 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
1
干预措施: SPM 962 (Drug)
2
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3
时间窗: baseline, end of maintenance period
Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 2 and Part 3. 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 2 assesses 13 items and 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
- Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3(baseline, end of maintenance period)
- Mean Change in UPDRS Part 2 Sum Score(Baseline, every two weeks)
- Efficacy Rate in UPDRS Part 2 Sum Score(Baseline, every two weeks)
- UPDRS Part 3 Sum Score(Baseline, every two weeks)
- Efficacy Rate in UPDRS Part 3 Sum Score(Baseline, every two weeks)
- UPDRS Part 1 Sum Score(Baseline, every two weeks)
- UPDRS Part 4 Sum Score(Baseline, every two weeks)
- Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4(Baseline, every two weeks)
- The Modified Hoehn and Yahr Stage(Baseline, end of maintenance period)