2024-516505-23-00招募中3 期
Long-Term Open-Label Study to Assess the Safety and Efficacy of Vatiquinone in Patients With Friedreich Ataxia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Adverse events (AEs)/serious adverse events (SAEs), laboratory abnormalities, vital signs, and electrocardiograms (ECGs)
研究概览
简要总结
To assess the long-term safety of vatiquinone in subjects with FA previously exposed to vatiquinone
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 65+ Years, 0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects with FA who completed and directly rolled over from a previous vatiquinone clinical study.
- •Males and females of childbearing potential must be willing to use an effective method of contraception (eg, implants, injectables, transdermal patch, combined oral contraceptives, barrier methods, and intrauterine devices) from the time consent is signed until 30 days after last dose of study drug or Early Termination Visit. Male subjects must agree not to donate sperm during the study and for at least 30 days after the last dose of study drug or Early Termination Visit. Note: Double-barrier method (ie, condom with spermicide) is required if no other methods of contraception are in use.
- •Subject provides consent to participate.
排除标准
- •Current participation in any other interventional study
- •Pregnancy or breastfeeding
结局指标
主要结局
Adverse events (AEs)/serious adverse events (SAEs), laboratory abnormalities, vital signs, and electrocardiograms (ECGs)
Adverse events (AEs)/serious adverse events (SAEs), laboratory abnormalities, vital signs, and electrocardiograms (ECGs)
次要结局
- Change from baseline in the mFARS and its 4 subscales (Upright Stability, Upper Limb, Lower Limb, Bulbar)
研究者
Mark Rance, MBBS BSc(Hons) MRCS(Eng)
Scientific
PTC Therapeutics Inc.
研究点 (4)
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