NL-OMON37243已完成2 期
Study NOG112264, a Phase II Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis - NOG112264
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
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
- 18 至 99（—）
入选标准
- •Diagnosis of familial or sporadic ALS (see protocol page 29 for details).
- •Onset of muscle weakness no more than 30 months before screening visit.
- •SVC of at least 65%.
- •If on riluzole, the dose must have been stable for at least 28 days.
- •Age 18 - 80 years inclusive.
- •Females of childbearing potential: reliable method of contraception.
排除标准
- •Other neuromuscular disorders (including a history of polio), which in the opinion of the investigator could have contributed to symptoms or could interfere with study evaluations.
- •Primary lateral sclerosis, monomelic ALS, ALS Parkinsonism dementia complex.
- •Patients requiring non-invasive or mechanical ventilation.
- •Diaphragmatic pacing.
- •Significant suicide risk.
- •Vaccination within 2 weeks.
- •Chronic (>3 months) use of systemic immunosuppressants including systemic steroids.
- •Pregnancy or breastfeeding.
研究者
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