Table 2.
Baseline characteristics of the modified intention-to-treat samplea
| Characteristic | PR-fampridine (n = 315) |
Placebo (n = 318) |
|---|---|---|
| Demographic characteristics | ||
| Age, years | 49.0 (9.8) | 48.8 (10.5) |
| Female, n (%) | 186 (59) | 180 (57) |
| Body mass index, kg/m2 | 25.6 (4.8) | 25.1 (4.4) |
| Clinical characteristics | ||
| Disease course, n (%) | ||
| Relapsing–remitting | 169 (54) | 155 (49) |
| Secondary progressive | 95 (30) | 99 (31) |
| Primary progressive | 41 (13) | 45 (14) |
| Progressive-relapsing | 10 (3) | 19 (6) |
| Median time since diagnosis, years | 10.0 | 10.0 |
| Median time since most recent relapse, years | 1.6 | 1.7 |
| Prior 4-aminopyridine use, n (%) | 31 (10) | 24 (8) |
| Distance walked (m), n (%)b | ||
| 0 | 77 (25) | 85 (28) |
| > 0 to < 100 | 56 (18) | 44 (15) |
| ≥ 100 to < 300 | 81 (27) | 82 (27) |
| ≥ 300 | 90 (30) | 91 (30) |
| MS-related motor symptoms, n (%) | ||
| Coordination/balance problemsc | 294 (95) | 300 (95) |
| Fatigued | 195 (63) | 211 (67) |
| Spasticityd | 276 (88) | 265 (84) |
| Weaknessd | 274 (88) | 281 (89) |
| Clinician-tested outcomes | ||
| EDSS score | 5.49 (0.92) | 5.48 (0.91) |
| Median (range) | 6.0 (4.0–7.0) | 5.5 (4.0–7.0) |
| EDSS score ≤ 6.0, n (%) | 246 (78) | 246 (77) |
| EDSS score 6.5 and 7.0, n (%) | 69 (22) | 72 (23) |
| TUG speed, ft/s | 0.38 (0.19) | 0.38 (0.20) |
| Range | 0.0–1.0 | 0.0–1.2 |
| TUG time, s | 24.9 (26.6) | 27.1 (42.0) |
| Range | 6.3–239.8 | 0–436.8 |
| BBS score | 40.6 (11.6) | 40.2 (11.8) |
| Range | 6.0–56.0 | 4.0–56.0 |
| Self-reported outcomes | ||
| MSWS-12 score | 63.6 (21.7) | 65.4 (21.9) |
| Range | 0–100 | 0–100 |
| MSIS-29 PHYS score | 52.4 (21.1) | 55.3 (21.0) |
| Range | 0.0–98.3 | 3.3–95.8 |
| ABILHAND score | 86.9 (15.8) | 84.3 (16.5) |
| Range | 0.9–100.0 | 26.0–100.0 |
Data are mean (standard deviation) unless otherwise specified
BBS Berg Balance Scale, EDSS Expanded Disability Status Scale, MS multiple sclerosis, MSIS-29 PHYS Multiple Sclerosis Impact Scale physical impact subscale, MSWS-12 12-item Multiple Sclerosis Walking Scale, PR prolonged-release, TUG Timed Up and Go
aFor most participants, race and ethnicity were not reported because of confidentiality regulations
bNumber of participants assessed: PR-fampridine, n = 304; placebo, n = 302
cNumber of participants assessed: PR-fampridine, n = 311; placebo, n = 316
dNumber of participants assessed: PR-fampridine, n = 312; placebo, n = 315