Investigation of the therapeutic effects of edaravone, a free radical scavenger, on amyotrophic lateral sclerosis (Phase II study)

被引:210
作者
Yoshino, Hiide
Kimura, Akio
机构
[1] Natl Ctr Neurol & Psychiat, Kohnodai Hosp, Dept Neurol, Chiba, Japan
[2] Gifu Univ Hosp, Dept Neurol, Gifu, Japan
来源
AMYOTROPHIC LATERAL SCLEROSIS | 2006年 / 7卷 / 04期
关键词
edaravone; ALS; clinical trial; ALSFRS-R; 3NT; oxidative stress;
D O I
10.1080/17482960600881870
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Amyotrophic lateral sclerosis (ALS) is a rare disease involving selective and progressive degeneration and disappearance of motor neurons. Oxidative stress is believed to contribute to its pathogenesis. We have investigated the efficacy and safety of edaravone, a free radical scavenger previously approved for treatment of acute cerebral infarction, in ALS patients. Within an open trial design, 20 subjects with ALS received either 30 mg (5 subjects) or 60 mg (15 subjects) of edaravone via intravenous drip once per day. Two weeks of administration was followed by a two-week observation period. This four-week cycle was repeated six times. The primary endpoint was the change in the revised ALS functional rating scale (ALSFRS-R) score, while the secondary endpoint was 3-nitrotyrosine (3NT) level in cerebrospinal fluid (CSF). Efficacy was evaluated in the 60 mg group. During the six-month treatment period, the decline in the ALSFRS-R score (2.3 +/- 3.6 points) was significantly less than that in the six months prior to edaravone administration (4.7 +/- 2.1 points); the difference between the two was 2.4 +/- 3.5 points (Wilcoxon signed rank test, p=0.039). In almost all patients, CSF 3NT, a marker for oxidative stress, was markedly reduced to almost undetectable levels at the end of the six-month treatment period. Data from the present study suggest that edaravone is safe and may delay the progression of functional motor disturbances by reducing oxidative stress in ALS patients.
引用
收藏
页码:241 / 245
页数:5
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