A Phase 2b Study of KW-6356 in Patients with Parkinson's Disease on Treatment with Levodopa-containing Preparations

Kyowa Kirin Co., Ltd.0 个研究点目标入组 486 人开始时间: 2018年9月18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 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 >= 15. (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.

•- 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 =< 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