Table 1

Baseline demographics and clinical disease characteristics (FAS analysis)12 13

Edaravone (n=69)Placebo (n=68)
Sex, n (%)
 Men38 (55)41 (60)
 Women31 (45)27 (40)
Mean age (years) (SD)60.5 (10)60.1 (10)
Mean duration of disease (years) (SD)1.13 (0.5)1.06 (0.5)
Initial symptom, n (%)
 Bulbar symptom16 (23)14 (21)
 Limb symptom53 (77)54 (79)
ALS diagnostic criteria, n (%)*
 Definite28 (41)27 (40)
 Probable41 (59)41 (60)
ALS severity, n (%)†
 Grade 122 (32)16 (24)
 Grade 247 (68)52 (76)
Mean ALSFRS-R score (SD)
 Before observation period43.6 (2.2)43.5 (2.2)
 Baseline (end of 12 weeks of observation)41.9 (2.4)41.8 (2.2)
Concomitant riluzole, n (%)63 (91)62 (91)
At the start of cycle 7Edaravone–
edaravone
Placebo–
edaravone
ALS severity, n (%)†
 Grade 18 (12.3)5 (8.6)
 Grade 227 (41.5)22 (37.9)
 Grade 321 (32.3)24 (41.4)
 Grade 49 (13.8)7 (12.1)
Mean ALSFRS-R score (SD)37.8 (4.9)34.8 (5.8)
  • *According to revised El Escorial criteria.

  • †According to Japan ALS severity classification (grades 1–5, with grade 5 being most severe).

  • ALS, amyotrophic lateral sclerosis; ALSFRS-R, Amyotrophic Lateral Sclerosis Functional Rating Scale—Revised ; FAS, full analysis set.