NL-OMON43897已完成2 期
Multicenter, open-label, single arm study to evaluate long-term safety, tolerability, and effectiveness of 10mg/kg olesoxime in patients with SMA - BN29854
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
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 last dose of olesoxime.
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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