A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of 40 mg Glatiramer Acetate Injection in Subjects With Amyotrophic Lateral Sclerosis (ALS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 366
- 试验地点
- 6
- 主要终点
- Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R)
研究概览
简要总结
Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties, which are believed to be of therapeutic value in ALS. The study treatment duration is 1 year (52 weeks).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.
- •Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit.
- •Slow VC test equal or greater than 70% of the predicted value.
- •The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.
- •Stable dose of riluzole for at least 8 weeks prior to screening.
- •Age - 18-70 (inclusive).
排除标准
- •The use of invasive or non-invasive ventilation.
- •Subject having undergone gastrostomy.
- •Subject with any clinically significant or unstable medical condition.
- •Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
- •Additional criteria per protocol.
研究组 & 干预措施
40 mg glatiramer acetate (GA)
Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day.
干预措施: 40 mg glatiramer acetate (Drug)
Placebo
Pre-filled syringe of matching placebo, administered subcutaneously once a day.
干预措施: Placebo (Drug)
结局指标
主要结局
Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R)
时间窗: Baseline, Weeks 4, 8, 12, 17, 22, 26, 31, 36, 40, 44, 48, 52
The ALSFRS-R is a questionnaire-based scale for monitoring the progression of disability in patients with ALS. It is composed of 12 items, each scored between 0 and 4.The total score, calculated as the sum of these 12 items, ranges from 0 to 48. The higher the score, the less disabled the participant. Timepoints after baseline were included in calculation of slope of change in ALSFRS-R. Slope is derived from the time by treatment interaction term from the Repeated Measures Analysis of Covariance model. Descriptive statistics of the slope are reported.
次要结局
- Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation(Baseline up to 52 weeks)