A Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects with Early Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Change of respiratory rate
研究概览
简要总结
A Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects with Early Parkinson's Disease. Primary objective of the study is to evaluate the safety and tolerability of MT101-5 400 mg and 600 mg oral tablet total daily dose compared to Placebo in subjects with Parkinson's Disease.
详细描述
The study will include three phases: a 4-week Screening Phase, a 12-week Double-Blind Treatment Phase, and a 4-week Follow-up Phase.
Screening Phase (Day -28 to Day -1, up to 28 days):
Screening phase is designed to determine subject's eligibility to proceed to Randomization and the Treatment Phase of the study. During this phase, a series of assessments will be performed to determine subject eligibility as per inclusion and exclusion criteria.
At the Screening Visit, prior to any study-related procedures, a written informed consent will be obtained from the subject by the Investigator or suitable qualified personnel. Screening procedures will be conducted per the study schedule of events. All screening information will be documented in the case report forms.
Subjects who meet eligibility criteria, but have some abnormal laboratory values, based on PI review a repeat laboratory sample may be collected. The repeat laboratory reports should be reviewed by the PI to confirm eligibility prior to randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Screening Phase (Day -28 to Day -1, up to 28 days):
Screening phase is designed to determine subject's eligibility to proceed to Randomization and the Treatment Phase of the study. During this phase, a series of assessments will be performed to determine subject eligibility as per inclusion and exclusion criteria.
Subjects who meet eligibility criteria, but have some abnormal laboratory values, based on PI review a repeat laboratory sample may be collected. The repeat laboratory reports should be reviewed by the PI to confirm eligibility prior to randomization.
Subjects who fail to meet eligibility criteria during the Screening phase will be considered screen failures and will be exited from the study. Subjects who meet the eligibility criteria will be scheduled for randomization visit.
干预措施: MT101-5 (Drug)
Randomization and Double-Blind Treatment Phase (TV0- TV3, 12 weeks):
Subjects who have successfully completed the Screening phase will enter the Randomization and Double-Blind treatment phase of the study. Subjects will take the assigned randomized treatment, MT101-5 at 400 mg, 600 mg or placebo for 12 weeks. MT101-5 and matching placebo are oral tablets that will be taken as six tablets two times a day (b.i.d.) at least 2 hours before or 2 hours after meal in the morning and evening daily during this study.
干预措施: MT101-5 (Drug)
Follow-up Phase (FUV, 4 weeks ± 3 days)
The follow-up phase will consist of a follow-up visit at the end of the Double-Blind Treatment phase.
干预措施: MT101-5 (Drug)
结局指标
主要结局
Change of respiratory rate
时间窗: Change from baseline to week 12 after the first study drug administration
Incidence of Treatment-Emergent Adverse Events (TEAEs)
时间窗: Change from baseline to week 12 after the first study drug administration
An adverse event (AE) is defined as any unfavorable or unintended sign, symptom, or disease that occurs or is reported by the patient to have occurred, or a worsening of a pre-existing condition. An adverse event may or may not be related to the study treatment.
Incidence of withdrawals due to Adverse Events (AEs)
时间窗: Change from baseline to week 12 after the first study drug administration
Incidence of withdrawals due to Adverse Events (AEs) defined above
Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: Change from baseline to week 12 after the first study drug administration
Suicidal ideation/suicidal behavior assessment tool. Score ranges from 2 to 25, with the higher number indicating more intense ideation.
Change of blood pressure (both systolic and diastolic blood pressures)
时间窗: Change from baseline to week 12 after the first study drug administration
ECG PR interval (msec)
时间窗: Change from baseline to week 12 after the first study drug administration
Incidence of serious adverse events (SAEs)
时间窗: Change from baseline to week 12 after the first study drug administration
Adverse event that results in death, is life threatening, Requires subject hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
Change of body temperature
时间窗: Change from baseline to week 12 after the first study drug administration
ECG ventricular rate (beats per minute)
时间窗: Change from baseline to week 12 after the first study drug administration
ECG QRS interval (msec)
时间窗: Change from baseline to week 12 after the first study drug administration
ECG QT interval (msec)
时间窗: Change from baseline to week 12 after the first study drug administration
ECG QTc interval (msec)
时间窗: Change from baseline to week 12 after the first study drug administration
次要结局
- Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) total score(Change from baseline to week 12 after the first study drug administration)
- Schwab and England (S&E) Scale total score(Change from baseline to week 12 after the first study drug administration)
- Parkinson's Disease Questionnaire (PDQ-39) total score(Change from baseline to week 12 after the first study drug administration)
- Hoehn and Yahr (H&Y) scale total score(Change from baseline to week 12 after the first study drug administration)
- Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scale score.(Change from baseline to week 12 after the first study drug administration)