EUCTR2015-001589-25-IT进行中（未招募）1 期
Multicenter, open-label, single arm study to evaluate long-term safety, tolerability, and effectiveness of 10mg/kg olesoxime in patients with SMA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 131
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participation in the previous studies (TRO19622CLEQ11150-1 or TRO19622CLEQ1275-1)
- •Able to comply with the study protocol, in the investigator’s judgment, including ability to take study treatment and perform study visits
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 117
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 56
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who, in the opinion of the investigator, are not suitable to participate in this open label study
- •Patients who have developed study drug hypersensitivity to olesoxime or one of the formulation excipients, including sesame oil
- •Concomitant or previous participation in any other investigational drug or device study within 90 days prior to screening
- •Concomitant or previous participation in a survival motor neuron protein gene (SMN2) targeting antisense oligonucleotide study within 6 months prior to screening
研究者
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