NCT04857359终止2 期
Phase 2b/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Dipraglurant (ADX48621) for the Treatment of Dyskinesia in Patients With Parkinson's Disease Receiving Levodopa-based Therapy
Addex Pharma S.A.41 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年8月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 41
- 主要终点
- Change from baseline on the Unified Dyskinesia Rating Scale (UDysRS) total score
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale (UDysRS). Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Parkinson's Disease on a stable regimen of antiparkinson's medications, including a levodopa preparation administered not less than 3 times daily.
- •Meet protocol-specified criteria for moderate to severe dyskinesia symptoms based on UDysRS and Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessments.
- •Meet protocol specified criteria for ON time with troublesome dyskinesia based on a standard PD home diary.
排除标准
- •Prior surgical treatment for Parkinson's Disease (e.g., deep brain stimulation).
- •Other neurological disease (including psychiatric disease and/or cognitive impairment) that, in the opinion of the investigator, would affect the patient's ability to complete study assessments.
- •Other significant medical condition that may affect the safety of the patient or preclude adequate participation in the study.
- •Pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, double-barrier method, intra-uterine device, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening.
- •Other protocol-defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Dipraglurant TID
Experimental
干预措施: Dipraglurant (Drug)
Placebo TID
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline on the Unified Dyskinesia Rating Scale (UDysRS) total score
时间窗: Baseline (Day 1) to Week 12
The UDysRS is a dyskinesia rating scale scored from 0-104 that evaluates involuntary movements associated with PD. A higher score indicates more severe dyskinesia.
次要结局
- Change from baseline in ON time without troublesome dyskinesia based on a standardized PD diary(Baseline (Day 1) to Week 12)
- Change from baseline in OFF time based on a standardized PD diary(Baseline (Day 1) to Week 12)
研究者
研究点 (41)
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