EUCTR2006-001688-49-IT进行中（未招募）不适用
A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of 40 mg Glatiramer Acetate for Injection in Subjects with Amyotrophic Lateral Scelorsis ALS - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Males and female subjects with probable, probable laboratory- supported or definite ALS according to the World Federation of Neurology El Escorial criteria. ALS may be familial or sporadic. 2. Subjects must have experienced their first ALS symptoms within 3 years prior to the screening visit. 3. Subjects must have a slow VC score equal to or greater than 70 of the predicted value for gender, height and age at the screening and baseline visit. 4. The sum of the 3 respiratory items from the ALSFRS-R must total at least 10 points at the screening and baseline visit. 5. Subjects taking riluzole must be on a stable dose for at least 8 weeks prior to the screening visit and their serum AST and ALT levels should not exceed three times the upper normal limit . 6. Subjects must be between 18 and 75 years of age inclusive. 7. Subjects and cargivers must be willing and able to provide written, informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The use of invasive or non-invasive ventilation. 2. Subjects who have undergone a gastrostomy. 3. Subjects with any clinically significant or unstable medical or surgical condition including cardiovascular, hepatic, pulmonary, renal, autoimmune, endocrine, metabolic or malignancy or any other condition that, in the investigator s opinion, places the subject at undue risk by participating in the study. 4. HBV or HCV seropositive subjects. 5. Subjects having used within the specified time prior to screening any of the following glatiramer acetate any previous use , mecasermin within 4 weeks prior to screening , rasagiline within 3 weeks prior to screening ,minocycline within 3 weeks prior to screening , dosage regimen of more than 600 mg/day coenzyme Q10 within 4 weeks prior to screening , any other marketed drug not approved for ALS within 12 weeks prior to screening , excluding symptomatic drugs for ALS and supplements. 6. Subjects participating in any other clinical trial for ALS within 12 weeks prior to screening or thereafter 7. Women who are pregnant or nursing at the time of screening, or intend to be during the study period. Women of child-bearing potential who do not practice feminine medically acceptable methods of contraception. 8. Subjects with current alcohol or drug abuse. 9. Subjects with known sensitivity to mannitol. 10. Subjects without a caregiver or healthcare professional to inject the study medication if unable to do so themselves 11. Subject unable at the time of the screening and baseline visit to comply with the planned schedule of study visits and study procedures.
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