Evaluation of Long-term Safety in Parkinsonian Patients With Intracerebroventricular Administration of A-dopamine (Anaerobic Dopamine) DIVE-FOLLOW UP
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Frequency of adverse events
研究概览
简要总结
Patients included in DIVE I have been receiving this treatment for several years as part of their participation in the study, which is scheduled to end on September 30, 2025. In this context, Lille University Hospital is offering patients still enrolled in DIVE I who wish to do so the opportunity to participate in a new clinical study, "Dive Follow Up," which is a longer-term follow-up study with, if necessary, a dose reduction until the experimental treatment is discontinued and an alternative treatment is put in place. It appears necessary to anticipate the discontinuation of treatment in order to limit as much as possible situations of abrupt discontinuation potentially associated with more severe clinical consequences. Thus, in order to limit the impact of discontinuing this treatment, the sponsor proposes a gradual and individualized reduction in the dose of A-dopamine and, whenever possible, an alternative treatment, in particular the new Scyova treatment.
The objective of this study will therefore be to monitor the safety of both long-term A-dopamine treatment and the consequences of discontinuation.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients included in the DIVE I study still being treated with A-dopamine.
- •Social security beneficiary.
- •Able to give free and informed consent to participate in the research.
- •Patient willing to comply with all study procedures and duration.
- •Patient not planning to change their lifestyle (nutritionally, physically, and socially) during their participation in the study.
排除标准
- •Patients not included in DIVE I and not treated with A-dopamine.
- •Presence of another serious condition that is life-threatening in the short or medium term, malnourished or cachectic patients.
- •Taking treatments containing guanethidine or its relatives, or non-selective and selective monoamine oxidase A inhibitors (iproniazid, moclobemide, toloxatone)
- •Patients already participating in another therapeutic trial involving the use of an experimental drug other than DIVE I or in an exclusion period
- •Isolated patients, defined as those without a caregiver present for at least 3 hours/day at the patient's home
研究组 & 干预措施
A-DOPAMINE
干预措施: A-DOPAMINE (Device)
结局指标
主要结局
Frequency of adverse events
时间窗: Through study completion, an average of 1 year
Recording of adverse events at any time. Frequency of adverse events reported by the patient and/or observed by the physician and/or home nurse during clinical examination, ECG, blood pressure, pulse, and standard laboratory tests.
次要结局
未报告次要终点