DOSE RANGE STUDY OF REMACEMIDE AS ADJUNCT TO LEVODOPA IN PARKINSON'S DISEASE

本研究的主要结局指标为：（1）耐受性： 受试者的比例能够完成最初的研究 分配的治疗剂量，（2）安全性：通过不良事件监测 频率、生命体征和临床实验室值，和（3）疗效： 改变清醒时处于“开启”状态的时间比例。 次要结局指标涉及疗效：（1）统一的 帕金森病评定量表（PDRS）评分和其他量表 在研究的7周内发生，（2）个体的变化 （3）临床总体印象评分的变化 (CGI)施瓦布和英格兰的日常生活活动，数字排序和 Beck抑郁评分和（4）平均值的剂量-反应关系 “开启”时间百分比从基线至末次观察值的变化 根据患者家庭日记，

The primary outcomes measures for this study are: (1) tolerability: what proportion of subjects are able to complete the study on the originally assigned treatment dosage, (2) safety: monitored by adverse event frequency, vital signs and clinical laboratory values, and (3) efficacy: change proportion of time spent in the "On" state during waking hours. Secondary outcome measures concern efficacy: (1) change in Unified Parkinson' Disease Rating Scale (UPDRS) scores and other scales occurring over the 7 weeks of the study, (2) change in the individual items of the UPDRS Part IV, (3) change in CLinical Global Impression (CGI), Schwab and England Activities of Daily Living, Digit Ordering and Beck Depression Scores, and (4) Dose-response relationship of mean change from baseline to last observed value in the percent of "On" time while awake per patient home diary.