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 |
