NCT00403104已完成2 期
A Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of Randomization
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
- 420
- 试验地点
- 26
- 主要终点
- Rate of decline of respiratory function determined as SVC over the 12 month treatment period
研究概览
简要总结
The purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared with placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable or clinically definite ALS (according to WNF EL Escorial diagnostic criteria, revised according to the Airlie House Conference 1998)
- •Onset of muscle weakness within 14 months randomization
- •Concomitant standard Riluzole therapy (50mg twice daily)
排除标准
- •Presence of a tracheotomy, mechanical ventilation or non-invasive ventilation
- •Requirement for prescription drugs used for potential neuroprotective benefit -
研究组 & 干预措施
E
Experimental
ONO-2506PO in the presence of Riluzole
干预措施: ONO-2506PO (Drug)
P
Placebo Comparator
Placebo in the presence of Riluzole
干预措施: ONO-2506PO (Drug)
结局指标
主要结局
Rate of decline of respiratory function determined as SVC over the 12 month treatment period
时间窗: 12 months
次要结局
- Survival(12, 18 months)
- Functional Assessment (ALSFRS-R)(12, 18 months)
- Muscle Strength (MRC muscle score)(12, 18 months)
- Quality of Life(12, 18 months)
研究者
研究点 (26)
Loading locations...
相似试验
已完成
2 期
Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in JapanParkinson's DiseaseNCT00212693Ono Pharmaceutical Co. Ltd165
已完成
2 期
Study of ONO-2506 in Patients With Acute Ischemic StrokeStrokeNCT00229177Ono Pharmaceutical Co. Ltd757
终止
2 期
A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic StrokeCerebrovascular AccidentNCT00046761Ono Pharma USA Inc1,320
已完成
1 期
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult SubjectsHealthy Adult SubjectsNCT01297582Ono Pharma USA Inc56
已完成
不适用
Clinical study to elucidate the efficacy of oral propranolol treatment for infantile hemangiomasInfantile hemangiomasJPRN-UMIN000012123Juntendo University School of Medicine150