A Clinical Study to Determine the Optimal Dose of WIN-1001X by Evaluating Its Efficacy and Safety in Patients With Early Parkinson's Disease: Double-blind, Randomized, Placebo-controlled, Multicenter, Phase II Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Change in MDS UPDRS Part Ⅲ
研究概览
简要总结
The purpose of this study is to determine the optimal dose of WIN-1001X for its therapeutic confirmatory study by comparing and evaluating the efficacy and safety of each dose group by conducting a therapeutic exploratory study on three dose groups of WIN-1001X 400 mg, 800 mg, and 1200 mg, and placebo group in patients with early Parkinson's disease.
详细描述
The primary objective of this study is to evaluate the difference in the change of MDS UPDRS Part Ⅲ between WIN-1001X 400 mg, 800 mg, and 1200 mg as the test drugs compared to placebo as the control drug after administering them for 12 weeks.
The secondary objectives of this study are to evaluate the therapeutic efficacy and safety of the 3 dose groups of WIN-1001X compared to placebo group by assessing the changes in MDS UPDRS Part Ⅲ after administering the investigational products for 4 and 8 weeks, the changes in MDS UPDRS Part Ⅰ, Part Ⅱ, Part Ⅰ+Part Ⅱ+Part Ⅲ, and Modified Hoehn and Yahr scale after administering for 4, 8, and 12 weeks, the changes in K-NMSS (Non-Motor Symptoms Scale), K-MoCA (Korean-Montreal Cognitive Assessment), K-PDQ-39 (Parkinson's Disease Questionnaire) score.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥30 years old at the time of informed consent
- •Subjects diagnosed with Parkinson's disease satisfying the UKPDSBB (United Kingdom Parkinson's Disease Society Brain Bank) Clinical Diagnostic Criteria and showing decreased dopamine transporters in the dopamine transporter imaging (e.g.: ¹⁸F-FP-CIT PET, etc.)
- •Modified Hoehn and Yahr stage ≤ 3.0
- •K-MMSE (Korean Mini-Mental State Examination) score ≥20 at the screening visit (visit 1)
- •Subjects who can understand and follow the instructions on this clinical study, and fully participate in the clinical study
- •MDS UPDRS Part Ⅱ+Part Ⅲ score ≥18 at baseline (visit 2)
- •Subjects who have voluntarily determined to participate in this study and signed the written informed consent form
排除标准
- •Atypical or secondary parkinsonism or benign tremulous parkinsonism
- •History of treatments with levodopa, dopamine agonists, anticholinergics, MAO-B inhibitors, COMT inhibitors, amantadine, or NMDA receptor antagonists (However, subjects who have not been administered such drugs for at least 6 months in a row and have no history of treatment within 4 weeks prior to their written consent can be enrolled)
- •In case the investigators determine the symptom control is difficult with placebo
- •Hypersensitivity to herbal medicine
- •Subjects with dementia whose K-MMSE score is ≤19, severe psychopathy requiring treatment or hallucination
- •Any disorder that may affect the absorption, distribution, metabolism, and excretion of drugs
- •History of surgical treatment for Parkinson's disease
- •Subjects who have been administered another investigational product within 30 days prior to screening
- •Female subjects who are pregnant or lactating, or who have child-bearing potential (i.e., (i) those who are not surgically non-infertile, or (ii) who are not using adequate contraceptive methods [including at least one of the barrier methods], or (iii) who are not sexually abstinent, or (iv) for whom at least 2 years have not elapsed since their last menstruation)
- •History of chronic alcohol or drug abuse within last 6 months
- •Subjects who are otherwise considered to be ineligible for this study on investigators' judgment
研究组 & 干预措施
Test Group 1
The randomized patients are administered 3 tablets of the investigational product (400mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
干预措施: WIN-1001X (Drug)
Test Group 2
The randomized patients are administered 3 tablets of the investigational product (800mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
干预措施: WIN-1001X (Drug)
Test Group 3
The randomized patients are administered 3 tablets of the investigational product (1200mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
干预措施: WIN-1001X (Drug)
Placebo group
The randomized patients are administered 3 tablets of the placebo drug twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in MDS UPDRS Part Ⅲ
时间窗: From baseline (0d) after administration of the investigational product for 12 weeks
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. MDS-UPDRS Part III measures motor examination. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).
次要结局
- Changes in each and total scores of K-NMSS(After administration of the investigational product for 4 and 12 weeks)
- Change in the Modified Hoehn and Yahr scale(After administration of the investigational product for 4, 8, and 12 weeks)
- Change in the MDS UPDRS Part Ⅲ(After administration of the investigational product for 4 and 8 weeks)
- Change in the MDS UPDRS Part Ⅰ+Part Ⅱ+Part Ⅲ(After administration of the investigational product for 4, 8, and 12 weeks)
- Change in the K-MoCA(After administration of the investigational product for 4 and 12 weeks)
- Change in the MDS UPDRS Part Ⅰ(After administration of the investigational product for 4, 8, and 12 weeks)
- Changes in the summary index and total scores of the K-PDQ-39(After administration of the investigational product for 4 and 12 weeks)
- Change in the MDS UPDRS Part Ⅱ(After administration of the investigational product for 4, 8, and 12 weeks)