EUCTR2015-001589-25-PL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 BID olesoxime in patients with Spinal Muscular Atrophy - OLEOS
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
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
- •For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 28 days after the last dose of olesoxime.
- •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
- •Pregnant or lactating, or intending to become pregnant during the study
研究者
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