TABLE 1.
Demography and baseline characteristics
| Characteristic | MSC‐NTF | Placebo |
|---|---|---|
| (N = 95) | (N = 94) | |
| Age (y), mean (SD) | 48.1 (9.71) | 49.1 (8.38) |
| Sex | ||
| Female, nn (%) | 27 (28.4) | 35 (37.2) |
| Male, n (%) | 68 (71.6) | 59 (62.8) |
| Baseline ALSFRS‐R, mean (SD) | 30.3 (6.5) | 31.4 (6.1) |
| ≤25, n (%) | 23 (24.2) | 21 (22.3) |
| > 25, n (%) | 72 (75.8) | 73 (77.7) |
| Baseline SVC (% predicted), mean (SD) | 76.2 (20.9) | 75.0 (19.8) |
| Time from first symptom to first treatment (mo), mean (SD) | 19.6 (5.17) | 19.1 (4.90) |
| Time from diagnosis (mo), mean (SD) | 6.8 (4.35) | 6.1 (4.80) |
| Site of disease onset | ||
| Limb, n (%) | 80 (84.2) | 73 (77.7) |
| Limb and bulbar, n (%) | 15 (15.8) | 21 (22.3) |
| El Escorial criteria | ||
| Possible, n (%) | 6 (6.3) | 6 (6.4) |
| Lab‐supported probable, n (%) | 15 (15.8) | 23 (24.5) |
| Probable, n (%) | 24 (25.3) | 31 (33.0) |
| Definite, n (%) | 50 (52.6) | 34 (36.2) |
| Use of riluzole at baseline | ||
| Yes, n (%) | 65 (68.4) | 56 (59.6) |
| No, n (%) | 30 (31.6) | 38 (40.4) |
| ALSFRS‐R | MSC‐NTF | Placebo |
|---|---|---|
| (N = 23) | (N = 21) | |
| Trial participants with ALSFRS‐R total score ≤ 25 at baseline | ||
| Average bulbar items with value of 0 at baseline, % | 7 | 6 |
| Average fine motor items with value of 0 at baseline, % | 49 | 33 |
| Average gross motor items with value of 0 at baseline, % | 42 | 32 |
| Average respiratory items with value of 0 at baseline, % | 1 | 0 |