A Phase 2b Study of KW-6356 in Subjects With Parkinson's Disease on Treatment With Levodopa-containing Preparations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) part III score
研究概览
简要总结
The primary objective of this study is to determine the recommended dose and evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partIII score between KW-6356 and placebo in patients with Parkinson's disease on treatment with Levodopa-containing preparations as an adjunctive therapy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject fulfills the UK Parkinson's Disease Society brain bank clinical diagnostic criteria.
- •Parkinson's disease patients in Stages 2 to 4 on the Modified Hoehn and Yahr Scale. (mH&Y, Evaluation at ON state for patients who experience Wearing-off phenomenon)
- •MDS-UPDRS partIII score of >=
- •(Evaluation at ON state)
- •Subject who are responsive to levodopa/DCI (carbidopa or benserazide) combination therapy and who have been on the therapy for 6 months or longer without interruption at enrollment.
- •Subject who have not started any new antiparkinsonian drugs and have been on a stable regimen of antiparkinsonian drugs in the 3 months before enrollment.
排除标准
- •Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment.
- •Use of any of the following drugs within 3 months (or 6 month in case of depot preparations) prior to enrollment; Antipsychotics, tiapride, metoclopramide, amoxapine, reserpine, tetrabenazine, methyldopa, papaverine, Levodopa/carbidopa intestinal gel and apomorphine hydrochloride injection
- •Treatment by transcranial magnetic stimulation (TMS) within 6 months prior to enrollment.
- •Neurosurgical operation for Parkinson's disease. (stereotactic surgery, deep brain stimulation or gamma knife)
- •Subject who have received administration of adenosine A2A receptor antagonist.
- •Either of the following criteria consecutively at screening and enrollment; Resting Pulse > 100 bpm Resting systolic blood pressure > 140 mmHg, or diastolic blood pressure > 90 mmHg
- •Significant dementia or a Mini-Mental State Examination (MMSE) score of =<
- •Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline.
- •Anyone otherwise considered unsuitable for the study by the investigator or subinvestigator including those who are unable to communicate or to cooperate with the investigator or subinvestigator.
研究组 & 干预措施
KW-6356 Low Dose
Oral administration
干预措施: KW-6356 (Drug)
KW-6356 High Dose
Oral administration
干预措施: KW-6356 (Drug)
placebo
Oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) part III score
时间窗: Up to 26 weeks after dosing
MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total score is the sum of the subscale scores for Parts III and ranges from 0 (no disability) to 136 (total dependence).
次要结局
- Change from baseline in the total hours of awake time per day spent in the OFF state. (total hours per day spent in the OFF state)(Up to 26 weeks after dosing)