Table 1

Baseline characteristics of study participants

Placebo
(n=123)
MethylcobalaminOverall
(n=370)
25 mg
(n=124)
50 mg
(n=123)
Sex
 Male71 (57.7)81 (65.3)71 (57.7)223 (60.3)
 Female52 (42.3)43 (34.7)52 (42.3)147 (39.7)
Age, years
 Mean±SD62.2±10.760.8±10.162.4±9.661.8±10.1
 <6561 (49.6)77 (62.1)65 (52.8)203 (54.9)
 ≥6562 (50.4)47 (37.9)58 (47.2)167 (45.1)
ALSFRS-R score at screening (mean±SD)42.1±3.541.7±3.841.9±3.841.9±3.7
ALSFRS-R at enrolment (mean±SD)40.1±3.539.8±4.039.9±4.040.0±3.8
Time lag from symptom onset to diagnosis, months (mean±SD)19.6±8.119.2±8.219.7±7.819.5±8.0
%FVC at screening (mean±SD)97.40±18.2293.75±17.2693.99±15.9795.04±17.21
%FVC at enrolment (mean±SD)92.83±20.0789.98±17.4589.39±17.5590.74±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
 Bulbar30 (24.4)29 (23.4)28 (22.8)87 (23.5)
 UMN60 (48.8)62 (50.0)61 (49.6)183 (49.5)
 LMN33 (26.8)33 (26.6)34 (27.6)100 (27.0)
ALS disease type
 Sporadic117 (95.1)122 (98.4)118 (95.9)357 (96.5)
 Familial6 (4.9)2 (1.6)5 (4.1)13 (3.5)
 Riluzole coadministration during the observation period110 (89.4)112 (90.3)110 (89.4)332 (89.7)
Diagnosis*
 Clinically definite ALS33 (26.8)43 (34.7)49 (39.8)125 (33.8)
 Clinically probable ALS62 (50.4)60 (48.4)49 (39.8)171 (46.2)
 Clinically probable, laboratory-supported ALS28 (22.8)21 (16.9)25 (20.3)74 (20.0)
ALS severity at enrolment
 Stage I14 (11.4)20 (16.1)17 (13.8)51 (13.8)
 Stage II109 (88.6)104 (83.9)106 (86.2)319 (86.2)
ALSFRS-R score change during the observation period
 −142 (34.1)45 (36.3)42 (34.1)129 (34.9)
 −246 (37.4)41 (33.1)45 (36.6)132 (35.7)
 −335 (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.