Table 1.
Demographic and baseline characteristics (intention‐to‐treat population 1 ).
| Placebo | Dimethyl fumarate | |
|---|---|---|
| (n = 35) | (n = 72) | |
| Age, mean (SD), years | 58.7 (11.0) | 60.1 (9.8) |
| Sex n (%) | ||
| Male | 23 (66) | 47 (65) |
| Female | 12 (34) | 25 (35) |
| Race, n (%) | ||
| White | 31 (89) | 64 (89) |
| Asian | 2 (6) | 3 (4) |
| Other | 2 (6) | 4 (6) |
| Smoking status | ||
| Smokers, n (%) | 4 (11) | 9 (13) |
| Number of cigarettes per day, mean (SD) | 16.3 (9.5) | 9.0 (5.7) |
| Diagnosis duration, mean (SD), days | 201.6 (165.5) | 242.5 (194.9) |
| Disease onset type, n (%) | ||
| Bulbar | 4 (11) | 13 (18) |
| Limb | 30 (86) | 59 (82) |
| Both | 1 (3) | 0 |
| ALS diagnosis, n (%) | ||
| Definite | 12 (34) | 17 (24) |
| Probable | 15 (43) | 39 (54) |
| Possible | 8 (23) | 16 (22) |
| ALSFRS‐R total score, mean (SD) | 38.7 (4.5) | 38.6 (5.5) 5 |
| Rate of disease progression/month | 2.2 (2.3) | 2.1 (1.8) |
| NI, mean (SD) 2 | 2.6 (4.5) | 2.5 (5.4) |
| SI, mean (SD) 2 | 4.0 (4.2) | 3.9 (3.7) |
| MRC score, mean (SD) 3 | 129.1 (17.9) | 127.5 (16.7) |
| %FVC, mean (SD) 4 | 85.2 (15.5) | 90.3 (16.5) |
| ALSSQoL score, mean (SD) 5 | 5.7 (0.7) | 5.3 (0.9) |
| Use of riluzole, n (%) | 27 (77) | 58 (81) |
ALS, amyotrophic lateral sclerosis; ALSFRS‐R, Revised Amyotrophic Lateral Sclerosis Functional Rating Scale; ALSSQoL, ALS‐specific quality of life; FEV1, forced expiratory volume in 1 sec; FVC, forced vital capacity; MRC, Medical Research Council; NI, neurophysiological index; SD, standard deviation; SI, split‐hand index.
1
The intention‐to‐treat population included all randomised patients.
2
n = 33 in the placebo group; n = 69 in the dimethyl fumarate group.
3
n = 34 in the placebo group; n = 71 in the dimethyl fumarate group.
4
FVC is FEV1/FVC (actual percentage).
5
n = 30 in the placebo group; n = 72 in the dimethyl fumarate group.