Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- ALS-FRS
研究概览
简要总结
The purpose of this trial is to study the effect of Memantine (uncompetitive, moderate affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the progression of Amyotrophic Lateral Sclerosis (ALS). Memantine is added to riluzole (the single drug approved to treat ALS).
详细描述
Phase 2/3 trial in ALS patients Double-blinded, parallel, randomized (2 blocs, bulbar/spinal onset)
Memantine + riluzole x Placebo + Memantine
Inclusion criteria:
- < 75 years at disease onset
- < 3 years of disease progression
- ALS-FRS > 24
- FVC > 60
- Probable or definite disease (revised El Escorial criteria)
- No other medical condition
- Normal blood tests
- Regular medication on riluzole > 1 month
- Nerve conduction studies ruling out conduction block
- EMG with widespread loss of motor units (revised El Escorial criteria)
- At least one hand with ADM strength > 2 on MRC scale
Duration - 2 years
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite or probable disease - revise El Escorial criteria
- •Normal blood tests
- •Riluzole treatment during 1 month or more
- •EMG in accordance with El Escorial criteria
排除标准
- •Other diseases (such as PNP)
- •Both ADM muscles < 3 on MRC scale
- •Conduction block on nerve conduction tests
- •Disease duration > 3 years
- •ALS-FRS < 25
- •Forced vital capacity - <60%
研究组 & 干预措施
1 - active
memantine + riluzole
干预措施: Memantine (Ebixa) (Drug)
1 - active
memantine + riluzole
干预措施: riluzole (Drug)
2
riluzole + placebo
干预措施: riluzole (Drug)
2
riluzole + placebo
干预措施: Placebo (Drug)
结局指标
主要结局
ALS-FRS
时间窗: 12 months
次要结局
- QoL, depression scale, strength (clinical evaluation), forced vital capacity(12 months)
- neurophysiology (motor unit counting, neurophysiological index)(12 months)