NCT00886977Unknown2 期
Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- ALSFRS-R
研究概览
简要总结
The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 25 and 65 years
- •ALS patients who can visit the clinic for six months
- •Forced Vital Capacity (FVC) > 70%
- •Patients who can walk by themselves
- •Change in ALSFRS-R score from -1 to -4 during 12 weeks before the initial administration
- •Patients who are willing to give informed consent
排除标准
- •Tracheotomy and invasive ventilation
- •Pregnant or possibly pregnant female patients
- •Female patients of childbearing potential who cannot practice contraception during and two years after the administration, and male patients who cannot practice contraception during and six months after the administration
- •Patients with clinically significant conditions such as cardiovascular, respiratory, haematological, and renal diseases.
- •Patients who are being treated with investigational drugs
- •Patients who are treated with other ALS drugs within 2 weeks prior to the first administration
结局指标
主要结局
ALSFRS-R
时间窗: 24w + follow-up period
Safety
时间窗: 24w and the follow up period
次要结局
- Manual Muscle Testing(24w + follow-up period)
- Grip/pinch strength(24w + followup period)
- Pulmonary function (forced vital capacity)(24w + follow-up period)
研究者
研究点 (1)
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