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

本研究的主要结局指标有：(1)耐受性：有多少比例的受试者能够按照最初指定的治疗剂量完成研究；(2)安全性：通过不良事件频率、生命体征和临床实验室值监测；(3)有效性：醒着时间处于“开”状态的时间比例的变化。次要结局指标涉及疗效：(1)在研究的7周内，统一帕金森病评定量表（UPDRS）评分和其他量表发生的变化，(2)UPDRS第四部分个别项目的变化，(3)临床总体印象（CGI）、Schwab和England日常生活活动、数字排序和Beck抑郁评分的变化，以及(4)每个患者家庭日记中清醒时“醒”的百分比从基线到最后观察值的平均变化的剂量-反应关系。本研究的招募工作已经完成。在整个研究范围内，最后一次随访将于1998年7月进行，之后将开始分析。该研究已停止登记。

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. Recruitment for this study is completed. Study-wide, the final follow-up visit will be in July, 1998 and analysis will commence thereafter. The study is closed to enrollment.