NCT05116813终止2 期
An Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy With or Without Concomitant Dopaminergic Medications
Addex Pharma S.A.7 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2021年10月25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
- 17
- 试验地点
- 7
- 主要终点
- Long-term safety and tolerability of dipraglurant as measured by incidence of adverse events
研究概览
简要总结
This open-label study is designed to assess the long-term safety and tolerability of dipraglurant in PD patients for up to 52 weeks (at doses of 150-300 mg per day) for patients that have completed an Addex sponsored double-blind clinical trial of dipraglurant.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed an Addex randomized controlled study of dipraglurant and, in the judgement of the Investigator, may benefit from open-label treatment
- •Able to take study drug 3 times daily and no less than 3 hours apart
- •Must be taking levodopa not less than 3 times daily throughout the study
- •Must maintain stable regimen of antiparkinson's medications (including levodopa) and be willing to continue the same doses and regimens for the first 4 weeks of the study
排除标准
- •Patient is judged by the Investigator to be inappropriate for the study (for reasons such as, but not limited to, significant noncompliance in the Addex randomized controlled study of dipraglurant)
- •Use of amantadine or amantadine ER throughout the study
- •Use of memantine throughout the study
- •Any use of marijuana or other cannabis/cannabinoid products for the first 4 weeks of study participation
- •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)
结局指标
主要结局
Long-term safety and tolerability of dipraglurant as measured by incidence of adverse events
时间窗: Baseline (Day 1) to Week 52
Testing the safety and tolerability of dipraglurant in patients with Parkinson's Disease Levodopa-induced dyskinesia based on the incidence of adverse events reported by patients and/or as identified by the Investigator based on clinical assessments conducted during the study.
次要结局
- Evaluate the continued utility of dipraglurant on dyskinesia as assessed by a change-from-baseline score on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS).(Baseline (Day 1) to Week 52)
研究者
研究点 (7)
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