NCT06034886Available不适用
Intermediate-Size Patient Population Expanded Access Protocol of Troriluzole in Patients With Spinocerebellar Ataxia (SCA)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
研究概览
简要总结
The purpose of this expanded access protocol is to provide access to the investigational drug troriluzole in patients with spinocerebellar ataxia (SCA).
详细描述
This is an Intermediate-Size Patient Population Expanded Access Protocol designed to provide treatment use of troriluzole to patients with spinocerebellar ataxia (SCA) who are considered to be eligible in the clinical judgement of the Investigator/treating physician. The population includes both troriluzole naive patients and patients participating in previous clinical trials with troriluzole (BHV4157-201 and BHV4157-206) who have a confirmed diagnosis of spinocerebellar ataxia.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a confirmed diagnosis of Spinocerebellar Ataxia (SCA), defined as either clinical evidence supporting diagnosis OR confirmed genotypic diagnosis.
- •Adequate hepatic function.
排除标准
- •Patient is known to have acute or chronic liver disease that is clinically significant in the judgement of the Physician.
- •Patient has a history of a clinically significant medical condition that would interfere with the patients ability to comply with the expanded access protocol or would place the patient at increased risk.
研究者
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