Table I.
Subject demographic characteristics.
| Item | Placebo (104) n (%) |
Edaravone (101) n (%) |
|---|---|---|
| Gender | ||
| male | 69 (66.3) | 63 (62.4) |
| Initial symptom | ||
| bulbar | 20 (19.2) | 18 (17.8) |
| limb | 84 (80.8) | 83 (82.2) |
| Diagnosis (El Escorial revisited) | ||
| definite | 21 (20.2) | 29 (28.7) |
| probable | 54 (51.9) | 52 (51.5) |
| probable laboratory-supported | 28 (26.9) | 20 (19.8) |
| possible | 1 (1.0) | 0 (0.0) |
| The Japanese severity classification | ||
| grade 1 | 40 (38.5) | 36 (35.6) |
| grade 2 | 64 (61.5) | 65 (64.4) |
| Use of riluzole | ||
| yes | 92 (88.5) | 90 (89.1) |
| Change in ALSFRS-R score during pre-observation | ||
| −4, −3 | 32 (30.8) | 29 (28.7) |
| −2, −1 | 72 (69.2) | 72 (71.3) |
| Item | Placebo (104) median (min-max) |
Edaravone (101) median (min-max) |
|---|---|---|
| Age (years old) | 58.5 (28–75) | 58.0 (29–73) |
| Body weight (kg) | 57.0 (37–109) | 57.0 (35–77) |
| Duration of disease (years) | 1.20 (0.3–3.0) | 1.30 (0.4–2.9) |
| ALSFRS-R score before pre-observation | 44.0 (35–48) | 43.0 (31–48) |
| ALSFRS-R score before treatment period | 42.0 (32–47) | 41.0 (29–47) |
ALSFRS-R: the revised amyotrophic lateral sclerosis functional rating scale.