Open-Label Access to ATH434 for Patients Who Completed Study ATH434-201 in France
Open-Label Extension Study to Provide Access to ATH434 in Patients With Multiple System Atrophy
研究概览
详细说明
This is a multicenter, open-label extension (OLE) study designed to provide continued access to the investigational product ATH434 for eligible participants with Multiple System Atrophy (MSA) who have successfully completed the prior Phase 2 clinical trial (ATH434-201) in France. Up to 5 participants will be enrolled. No new participants will be recruited or enrolled in this study.
The primary objective is to monitor long-term safety, tolerability, and clinical response. Eligible participants will receive ATH434 at a dose of 75 mg twice daily (BID) to be taken with food.
The study is divided into two operational phases:
Initial Treatment Phase: Participants will receive treatment for a planned duration of 12 months.
Extension Phase: Participants may continue treatment beyond the initial 12 months based on the investigator's clinical judgment of ongoing benefit, safety, and tolerability. Continued eligibility will be re-evaluated and documented every 3 months.
Participants will undergo a combination of in-clinic and remote visits to perform safety monitoring, clinical evaluations, and investigational product accountability.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Alterity Clinical Trials
- 电话号码：+1 888-556-7582
- 邮箱：clinicaltrials@alteritytx.com
学习地点
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Midi-Pyrenees
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Toulouse、Midi-Pyrenees、法国、31300
- Hôpital Pierre-Paul Riquet
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New Aquitaine
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Bordeaux、New Aquitaine、法国、33076
- Centre Hospitalier Universitaire De Bordeaux
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Provence-Alpes-Côte d'Azur Region
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Marseille、Provence-Alpes-Côte d'Azur Region、法国、13005
- Hôpital de la Timone
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Île-de-France Region
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Paris、Île-de-France Region、法国、75013
- Hôpital Universitaire Pitié Salpêtrière
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Completed Alterity protocol ATH434-201.
- Expected to benefit from treatment from treatment with ATH434, in the opinion of the Investigator.
Exclusion Criteria:
- Discontinued prior ATH434 treatment (ATH434-201) for any reason.
- Significant medical or psychiatric condition that may decrease the benefit-risk ratio of participation in this program to an unacceptable level, as per the Investigator's opinion.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：ATH434 75mg BID
Participants who completed the prior ATH434-201 Phase 2 trial will receive ATH434 75 mg orally twice daily (BID).
Treatment consists of an initial 12-month treatment phase, followed by an ongoing extension phase based on investigator assessment of continued clinical benefit, safety, and tolerability
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ATH434 75 mg tablets administered orally twice daily (BID).
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence, Severity, and Relationship of Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Baseline to completion of study treatment, an average of 1 year.
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All AEs will be reviewed at every participant contact and documented in the CRF.
All SAEs will be reported within 24 hours of awareness in accordance with local regulatory requirements.
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Baseline to completion of study treatment, an average of 1 year.
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Change From Baseline in Clinical Laboratory Parameters
大体时间：Baseline to completion of study treatment, an average of 1 year.
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Clinical laboratory parameters include hematology and blood chemistry panels.
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Baseline to completion of study treatment, an average of 1 year.
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Change From Baseline in Vital Signs
大体时间：Baseline to completion of study treatment, an average of 1 year.
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Vital signs include blood pressure, pulse, temperature, and respiration rate.
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Baseline to completion of study treatment, an average of 1 year.
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Duration of Exposure to ATH434
大体时间：Baseline to completion of study treatment, an average of 1 year.
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Total duration of treatment with investigational product per participant.
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Baseline to completion of study treatment, an average of 1 year.
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Cumulative Dose of ATH434
大体时间：Baseline to completion of study treatment, an average of 1 year.
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Total cumulative dose of investigational product administered per participant.
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Baseline to completion of study treatment, an average of 1 year.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.