Baseline characteristics of study participants
| Placebo (n=123) | Methylcobalamin | Overall (n=370) | ||
| 25 mg (n=124) | 50 mg (n=123) | |||
| Sex | ||||
| Male | 71 (57.7) | 81 (65.3) | 71 (57.7) | 223 (60.3) |
| Female | 52 (42.3) | 43 (34.7) | 52 (42.3) | 147 (39.7) |
| Age, years | ||||
| Mean±SD | 62.2±10.7 | 60.8±10.1 | 62.4±9.6 | 61.8±10.1 |
| <65 | 61 (49.6) | 77 (62.1) | 65 (52.8) | 203 (54.9) |
| ≥65 | 62 (50.4) | 47 (37.9) | 58 (47.2) | 167 (45.1) |
| ALSFRS-R score at screening (mean±SD) | 42.1±3.5 | 41.7±3.8 | 41.9±3.8 | 41.9±3.7 |
| ALSFRS-R at enrolment (mean±SD) | 40.1±3.5 | 39.8±4.0 | 39.9±4.0 | 40.0±3.8 |
| Time lag from symptom onset to diagnosis, months (mean±SD) | 19.6±8.1 | 19.2±8.2 | 19.7±7.8 | 19.5±8.0 |
| %FVC at screening (mean±SD) | 97.40±18.22 | 93.75±17.26 | 93.99±15.97 | 95.04±17.21 |
| %FVC at enrolment (mean±SD) | 92.83±20.07 | 89.98±17.45 | 89.39±17.55 | 90.74±18.41 |
| %FVC change during the observation period (mean±SD) | −4.57±10.63 | −3.76±9.36 | −4.59±8.77 | −4.31±9.60 |
| Onset type | ||||
| Bulbar | 30 (24.4) | 29 (23.4) | 28 (22.8) | 87 (23.5) |
| UMN | 60 (48.8) | 62 (50.0) | 61 (49.6) | 183 (49.5) |
| LMN | 33 (26.8) | 33 (26.6) | 34 (27.6) | 100 (27.0) |
| ALS disease type | ||||
| Sporadic | 117 (95.1) | 122 (98.4) | 118 (95.9) | 357 (96.5) |
| Familial | 6 (4.9) | 2 (1.6) | 5 (4.1) | 13 (3.5) |
| Riluzole coadministration during the observation period | 110 (89.4) | 112 (90.3) | 110 (89.4) | 332 (89.7) |
| Diagnosis* | ||||
| Clinically definite ALS | 33 (26.8) | 43 (34.7) | 49 (39.8) | 125 (33.8) |
| Clinically probable ALS | 62 (50.4) | 60 (48.4) | 49 (39.8) | 171 (46.2) |
| Clinically probable, laboratory-supported ALS | 28 (22.8) | 21 (16.9) | 25 (20.3) | 74 (20.0) |
| ALS severity at enrolment | ||||
| Stage I | 14 (11.4) | 20 (16.1) | 17 (13.8) | 51 (13.8) |
| Stage II | 109 (88.6) | 104 (83.9) | 106 (86.2) | 319 (86.2) |
| ALSFRS-R score change during the observation period | ||||
| −1 | 42 (34.1) | 45 (36.3) | 42 (34.1) | 129 (34.9) |
| −2 | 46 (37.4) | 41 (33.1) | 45 (36.6) | 132 (35.7) |
| −3 | 35 (28.5) | 38 (30.6) | 36 (29.3) | 109 (29.5) |
Data were compared among groups using one-way analysis of variance for continuous, χ2 test for nominal and Kruskal-Wallis test for ordinal variables. Unless otherwise stated, values represent the number followed by the percentage of participants.
*Diagnoses were made according to the revised El Escorial criteria (Airlie House criteria).
ALS, amyotrophic lateral sclerosis; ALSFRS-R, Revised ALS Functional Rating Scale; %FVC, per cent-predicted forced vital capacity; LMN, lower motor neuron; UMN, upper motor neuron.