A late phase II clinical trial of KDT-3594 in patients with advanced Parkinson's disease with levodopa

Kissei Pharmaceutical Co., Ltd.0 个研究点目标入组 150 人开始时间: 待定最近更新: 2025年4月10日

适应症

试验速览

暂无简介。

•Patients diagnosed with PD according to the Parkinson's disease society brain bank clinical diagnostic criteria of the UK Parkinson's Disease Society
•Patients who are being treated with levodopa or levodopa combination drugs and have any of the following troublesome symptoms or conditions:
•Patients with wearing-off phenomenon
•Patients with ON-/OFF-phenomenon
•Patients with no-on/delayed on phenomenon
•Patients with inadequate response to levodopa

•Patients suspected of having parkinsonism other than PD based on medical history, physical findings, laboratory test values, dopamine transporter-single photon emission computed tomography (DAT-SPECT), etc.
•Patients who have undergone neurosurgical therapy for PD (e.g., stereotactic thalamotomy and pallidotomy and deep brain stimulation) or who are scheduled to undergo surgical therapy during the trial period
•Patients complicated with overt dementia or a Mini-Mental State Examination (MMSE) score of < 24 at the start of the screening period

MDS-UPDRS Part II+III (ON-time) total score

时间窗: Week 17 of the treatment period

Change from baseline

Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score
Change from baseline in the MDS-UPDRS Part I, II, III, and IV (ON-time) total score
Response rate in the MDS-UPDRS Part III (ON-time) total score
Change from baseline in the proportion of OFF-time in awake time
Incidence of adverse events and treatment-related adverse events
Changes from baseline in clinical laboratory parameters (hematology, blood chemistry, and urinalysis)
Changes from baseline in vital signs (blood pressure, pulse rate, and temperature) and weight

发起方