2025-524317-88-00招募中2 期
Open-Label Extension Study to Provide Access to ATH434 in Patients with Multiple System Atrophy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 8
- 主要终点
- Assessment of long term safety and tolerability based on incidence and severity of AEs and SAEs, changes in laboratory and vital sign parameters including orthostatic measures, exposure to ATH434, treatment discontinuations due to adverse events, and deaths.
研究概览
简要总结
To assess the long-term safety and tolerability of ATH434 in participants with MSA receiving open-label treatment in this extension study.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Completed the ATH434-201 study in accordance with the study protocol requirements.
- •Willing and able to provide written informed consent prior to any study-related procedure.
- •Able to attend scheduled study visits (clinic and remote) as specified in the Schedule of Events.
- •Expected, in the investigator’s judgement, to benefit from treatment with ATH
- •Female participants must meet one of the following criteria: • Postmenopausal (defined as ≥12 months of spontaneous amenorrhea with a serum follicle stimulating hormone [FSH] level consistent with postmenopausal status at screening, or • Surgically sterile (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy performed ≥6 months prior to enrollment), or • Of childbearing potential and compliant with the contraception requirements described in Section 7.4.
- •Male participants must agree to comply with the contraception requirements described in Section 7.4.3.
排除标准
- •Discontinued prior ATH434-201 treatment for any reason.
- •Any medical condition or psychiatric condition that, in the opinion of the investigator, results in an unfavorable benefit–risk ratio with ATH434 treatment. This includes but is not limited to: • Hemoglobin (male <13 g/dL; female <11 g/dL); • Abnormal liver tests: ALT and/or AST > 3 × ULN or Total bilirubin > 1.5 x ULN; • Renal impairment: creatinine clearance < 50 mL/min, as estimated by the Cockcroft–Gault formula; • Other clinically relevant abnormalities considered significant by the Investigator.
- •History of certain neurological event or abnormalities.
- •Use of prohibited concomitant medications that can interfere with ATH434 metabolism. (See Section 7.1).
- •Known hypersensitivity to ATH434 or to any excipient in the formulation.
- •Pregnant or breastfeeding women or planning to become pregnant or breastfeeding while participating in the study.
- •Participated in an interventional medical research study/program within 30 days or 5 drug half-lives, whichever is longer, at the time of enrollment, or planning to do so while participating in the study.
研究组 & 干预措施
ATH434-DP2
Test
干预措施: ATH434-DP2 (Drug)
结局指标
主要结局
Assessment of long term safety and tolerability based on incidence and severity of AEs and SAEs, changes in laboratory and vital sign parameters including orthostatic measures, exposure to ATH434, treatment discontinuations due to adverse events, and deaths.
Assessment of long term safety and tolerability based on incidence and severity of AEs and SAEs, changes in laboratory and vital sign parameters including orthostatic measures, exposure to ATH434, treatment discontinuations due to adverse events, and deaths.
次要结局
未报告次要终点
研究者
David Stamler, MD
Scientific
Alterity Therapeutics Limited
研究点 (8)
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