NCT00445172已完成2 期
A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 135
- 主要终点
- Number of participants with Adverse Events as a Measure of safety
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of long-term E0302 administration in patients with 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have completed Phase II/III study of E0302 (E0302-J081-761, hereafter referred to as Study 761) except for those patients who discontinued the treatment of Study
- •Completed patients are defined as those who completed the treatment period of Study 761, those on 24-hour use of non-invasive positive pressure ventilation (NIPPV), or those who eventually resulted in the use of NIPPV.
- •Patients who are able to submit written informed consent. If patients are duly capable of study consent but are unable to sign (or affix a seal) by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation.
排除标准
- •Patients with cognitive impairment.
- •Pregnant women or women who may have a possibility of becoming pregnant.
- •Patients or their partners who are not willing to use reliable contraception.
- •Patients with severe disease in the renal, cardiovascular, hematological, or hepatic system (severe disease will be judged referring to "Ministry of Health, Labor and Welfare (MHLW) Drug Safety Dept. Notification No. 80, Drug Safety Classification Criteria for Severity of Adverse Drug Reaction by Medicinal Products, Grade 3." However, an event due to the primary disease will be precluded).
- •Patients with malignant tumor.
- •Patients who participated in another clinical study after the completion of Study
- •Patients with present illness or history of drug allergy or severe allergic disease (anaphylactic shock).
- •Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.
研究组 & 干预措施
1
Experimental
干预措施: E0302 (mecobalamin) (Drug)
结局指标
主要结局
Number of participants with Adverse Events as a Measure of safety
时间窗: Every 3 months
次要结局
- Survival rate(Every 3 months)
- Functional rating scale(Every 3 months)
- Percent-predicted forced vital capacity (%FVC.)(Every 3 months)
研究者
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