Open-Label Extension Study to Provide Access to ATH434 in Patients With Multiple System Atrophy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Change From Baseline in Vital Signs
研究概览
简要总结
This multicenter open-label extension study conducted in France is designed to provide ATH434 orally BID to eligible patients who completed the Phase 2 study ATH434-201, and who may benefit from this treatment according to the evaluation by the Investigator.
详细描述
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.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed Alterity protocol ATH434-
- •Expected to benefit from treatment from treatment with ATH434, in the opinion of the Investigator.
排除标准
- •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.
结局指标
主要结局
Change From Baseline in Vital Signs
时间窗: Baseline to completion of study treatment, an average of 1 year.
Vital signs include blood pressure, pulse, temperature, and respiration rate.
Incidence, Severity, and Relationship of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline to completion of study treatment, an average of 1 year.
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.
Change From Baseline in Clinical Laboratory Parameters
时间窗: Baseline to completion of study treatment, an average of 1 year.
Clinical laboratory parameters include hematology and blood chemistry panels.
Duration of Exposure to ATH434
时间窗: Baseline to completion of study treatment, an average of 1 year.
Total duration of treatment with investigational product per participant.
Cumulative Dose of ATH434
时间窗: Baseline to completion of study treatment, an average of 1 year.
Total cumulative dose of investigational product administered per participant.
次要结局
未报告次要终点