Table 1.

Details of the 18 enrolled trial participants

Parameter	All participants (n = 18)	High dose (n = 9)	Low dose (n = 9)
Age (years)	57.5 ± 10.5	56.5 ± 11.4	58.4 ± 10.1
Sex
Female	10 (55.6%)	5 (55.6%)	5 (55.6%)
Male	8 (44.4%)	4 (44.4%)	4 (44.4%)
Ethnicity
Hispanic or Latino	2 (11.1%)	2 (22.2%)	0 (0%)
Non-Hispanic or Latino	16 (88.9%)	7 (77.8%)	9 (100%)
Race
White	18 (100%)	9 (100%)	9 (100%)
Forced vital capacity (max %-pred)	92.1 ± 22.0	95.1 ± 22.8	89.1 ± 22.2
Weight (kg)	83.5 ± 13.8	85.4 ± 17.4	81.5 ± 9.78
Months since symptom onset	18.8 ± 8.1	16.7 ± 5.0	20.8 ± 10.2
Months since diagnosis	10.7 ± 5.8	11.7 ± 5.3	9.6 ± 6.5
BMI (kg m−2)	27.7 ± 3.47	28.2 ± 4.00	27.3 ± 3.01
Onset site
Bulbar	2 (11.1%)	1 (11.1%)	1 (11.1%)
Limb	16 (88.9%)	8 (88.9%)	8 (88.9%)
Taking riluzole
No	6 (33.3%)	5 (55.6%)	1 (11.1%)
Yes	12 (66.7%)	4 (44.4%)	8 (88.9%)
Family history of ALS
No	15 (83.3%)	7 (77.8%)	8 (88.9%)
Unknown	2 (11.1%)	2 (22.2%)	0 (0%)
Yes	1 (5.6%)	0 (0.0%)	1 (11.1%)
Lumbar UMN clinical signs
No	3 (16.7%)	2 (22.2%)	1 (11.1%)
Yes	15 (83.3%)	7 (77.8%)	8 (88.9%)
Lumbar LMN clinical signsa
No	5 (27.8%)	1 (11.1%)	4 (44.4%)
Yes	13 (72.2%)	8 (88.9%)	5 (55.6%)
Lumbar electromyography signs	18 (100%)	9 (100%)	9 (100%)
ALSFRS-R total score	36.8 ± 4.7	37.9 ± 5.3	35.8 ± 4.0
Bulbar subscore	10.6 ± 2.23	10.9 ± 1.96	10.2 ± 2.54
Fine motor subscore	8.83 ± 2.36	9.78 ± 2.33	7.89 ± 2.09
Gross motor subscore	6.67 ± 2.00	6.44 ± 1.88	6.89 ± 2.20
Respiratory subscore	10.8 ± 1.70	10.8 ± 1.72	10.8 ± 1.79
Post-operative month at death	23.9 ± 8.7	25.9 ± 8.3	22.3 ± 9.3

Mean ± s.d.

^aExamples of lumbar LMN clinical signs include weakness, flaccidity, atrophy and fasciculations.