Table I.
Baseline characteristics.
| Primary analysis (n=60)
|
Secondary analysis (n=86)
|
|||
|---|---|---|---|---|
| Celecoxib/Creatine | Minocyline/Creatine | Celecoxib/Creatine | Minocyline/Creatine | |
| No. of patients randomized (%) | 30 (50.0) | 30 (50.0) | 47 (54.7) | 39 (45.3) |
| Sex, no. (% within drug group) | ||||
| Male | 23 (76.7) | 15 (50.0) | 36 (76.6) | 23 (59.0) |
| Female | 7 (23.3) | 15 (50.0) | 11 (23.4) | 16 (41.0) |
| Age at enrollment, years (Mean) (SD) | 55.43 (10.89) | 58.50 (13.24) | 55.62 (11.48) | 58.62 (12.87) |
| Race, no. (%) | ||||
| White | 26 (86.7) | 27 (90.0) | 41 (87.2) | 35 (89.7) |
| Black or African American | 1 (3.3) | 1 (3.3) | 3 (6.4) | 1 (2.6) |
| Asian | 1 (3.3) | 0 (0.0) | 1 (2.1) | 0 (0.0) |
| American Indian/Alaskan Native | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Other | 2 (6.7) | 2 (6.7) | 2 (4.3) | 3 (7.7) |
| Hispanic ethnicity (race classified as Other for 5 and as White for 1): no. (%) | 2 (6.7) | 2 (6.7) | 2 (4.8) | 4 (10.3) |
| Site of onset, no. (%) | ||||
| Arm | 11 (36.7) | 15 (50.0) | 18 (38.2) | 20 (51.3) |
| Leg | 12 (40.0) | 10 (33.3) | 16 (34.0) | 11 (28.2) |
| Bulbar | 7 (23.3) | 5 (16.7) | 13 (27.7) | 8 (20.5) |
| Progression rate, no. (%) | ||||
| Slow | 18 (60.0) | 17 (56.7) | 25 (53.2) | 23 (59.0) |
| Fast | 12 (40.0) | 13 (43.3) | 22 (46.8) | 16 (41.0) |
| ALSFRS-R: Mean (SD) | 38.73 (5.11) | 38.60 (4.59) | 38.79 (4.91) | 38.51 (4.77) |
| FVC: Mean percent predicted (SD) | 88.90 (13.64) | 94.07 (15.11) | 87.96 (15.02) | 92.08 (15.13) |
| TUG: Mean time (SD) | 20.54 (35.59) | 11.91 (5.89) | 19.89 (29.98) | 11.26 (5.24) |
| Mean number of days from symptom onset to enrollment (SD) | 734.10 (415.96) | 703.93 (401.12) | 650.72 (396.83) | 732.56 (381.90) |
| On riluzole, no. (%) | 20 (66.7) | 21 (70.0) | 28 (59.6) | 27 (69.2) |
| Weight, pounds: Mean (SD) | 173.47 (24.52) | 174.17 (33.19) | 177.66 (32.21) | 171.77 (30.95) |
ALSFRS-R: Amyotrophic Lateral Sclerosis Functional Rating Scale, Revised; FVC: Forced Vital Capacity.