A Late Phase II Clinical Trial of KDT-3594 in Patients With Advanced Parkinson's Disease With Levodopa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score at Week 17 of the treatment period
研究概览
简要总结
This trial is a late phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety, and pharmacokinetics of KDT-3594 administered at escalating doses ranging from 0.25 to 2 mg per day for 17 weeks in patients with advanced PD with levodopa.
详细描述
This trial is a late phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety, and pharmacokinetics of KDT-3594 administered once daily in patients with advanced PD with levodopa.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo capsules will be orally administered at escalating doses ranging from 0.25 to 2 mg per day for 17 weeks.
干预措施: Placebo (Drug)
KDT-3594
KDT-3594 capsules will be orally administered at escalating doses ranging from 0.25 to 2 mg per day for 17 weeks.
干预措施: KDT-3594 (Drug)
结局指标
主要结局
Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score at Week 17 of the treatment period
时间窗: Up to 17 weeks
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question, a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. In all parts, a higher score indicated more severe symptoms of PD, and the score range of each part are as follows. * Part I: 0-52 * Part II: 0-52 * Part III: 0-132 * Part IV: 0-24 * Total Score: 0-260 * Part II+III: 0-184 (MDS-UPDRS Part II and III combined score equals the sum of Parts II and III (range 0-184)).
次要结局
- Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score(Up to 17 weeks)
- Change from baseline in the MDS-UPDRS Part I, II, III, and IV (ON-time) total score(Up to 17 weeks)
- Response rate in the MDS-UPDRS Part III (ON-time) total score(Up to 17 weeks)
- Change from baseline in the proportion of OFF-time in awake time(Up to 17 weeks)
- Change from baseline in OFF-time(Up to 17 weeks)
- Incidence of adverse events and treatment-related adverse events(Up to 17 weeks)