An Early Phase 2 Study of KW-6356 in Subject with Early Parkinson's Disease.

Kyowa Hakko Kirin Co., Ltd.0 个研究点目标入组 150 人开始时间: 2016年10月4日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Subject fulfills the UK Parkinson's Disease Society brain bank clinical diagnostic criteria
•-Parkinson's disease patients in Stages 1 to 3 on the Modified Hoehn and Yahr Scale
•-MDS-UPDRS partIII score of >= 15

•-Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment.
•-Use of any of the specified antiparkinsonian drugs and dopamine antagonists during the specifided period.
•-Treatment with levodopa/DCI at any time in the past for a period of 4 weeks or more
•-Neurosurgical operation for Parkinson's disease (stereotactic surgery, deep brain stimulation or
•gamma knife), or treatment by transcranial magnetic stimulation (TMS).
•-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 =< 23
•-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.

发起方

Kyowa Hakko Kirin Co., Ltd.