Table 2.
Study randomization and demographics
| Category | Patients (n) | % |
|---|---|---|
| Randomization | ||
| Active then placebo | 31 | 51.7 |
| Placebo then active | 29 | 48.3 |
| Sex | ||
| Female | 26 | 43.3 |
| Male | 34 | 56.7 |
| Race | ||
| Asian | 1 | 1.7 |
| Black/African | 2 | 3.3 |
| White/Caucasian | 57 | 95.0 |
| Ethnicity | ||
| Non-Hispanic or Latino | 60 | 100 |
| Patients taking riluzole | 21 | 35.0 |
| Limb onset | 22 | 36.7 |
| Bulbar onset | 38 | 63.3 |
| Baseline values | ||
| Age (y) | 57.8 ± 11.1 | |
| Age range (y) | 26–78 | |
| CNS-BFS total score | 58.2 ± 13.4 | |
| ALSFRS-R total score | 34.6 ± 7.0 | |
| Mean time symptom onset to trial enrollment (mo) | 23.3 ± 21.6 | |
| Mean time ALS diagnosis to trial enrollment | 9.2 ± 13.3 | |
Data are mean ± SD unless otherwise indicated. CNS-BFS = Center for Neurologic Study Bulbar Function Scale; ALSFRS-R = Amyotrophic Lateral Sclerosis Function Rating Scale Revised; ALS = Amyotrophic Lateral Sclerosis