A Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 主要终点
- Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of TVP-1012 (1 mg/day) in Japanese participants with early Parkinson's disease.
详细描述
This is a multicenter, open-label, long-term, extension, phase 3 study to evaluate the safety and efficacy of long-term administration of TVP-1012 at 1 mg for another 26 weeks in participants with early Parkinson's disease who have completed the preceding TVP-1012/CCT-001 (NCT02337725) study.
Among participants of the TVP-1012/CCT-001 study, those consenting to participate in this study prior to complete the preceding study and fulfilling the eligibility criteria will be enrolled in this study. From the day after the Visit 8 of the preceding study, participants will receive 1 mg of TVP-1012 once daily for 26 weeks in an unblinded manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The participant has completed the preceding study.
- •The participant has shown no safety issues during the study treatment in the preceding study, in the opinion of the investigator or subinvestigator.
排除标准
- •The participant has undergone blood collection of >= 400 mL within 90 days prior to the start of treatment in this study.
- •The participant is required to take any of the excluded medications or treatments.
- •The participant is required surgery or hospitalization for surgery during the study period.
研究组 & 干预措施
TVP-1012 1mg Group
TVP-1012 (1 mg/day) once daily, either before or after breakfast.
干预措施: TVP-1012 1mg (Drug)
结局指标
主要结局
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
时间窗: Up to 52 weeks
Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).
次要结局
- Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score(Baseline to End of treatment (Week 52))
- Number of Participants With TEAE Related to Clinical Laboratory Tests(Up to 52 weeks)
- Number of Participants With Markedly Abnormal Vital Signs Values(Up to 52 weeks)
- Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)(Up to 52 weeks)
- Number of Participants With TEAE Related to Body Weight (Weight Loss)(Up to 52 weeks)