Table 1.
Placebo (n = 64) | Fampridine-PR 10 mg BID (n = 68) | Total (n = 132) | |
---|---|---|---|
Mean age, years (SD) | 49.8 (9.3) | 49.8 (8.7) | 49.8 (9.0) |
Male, n (%) | 31 (48) | 30 (44) | 61 (46) |
Race, n (%) | |||
White | 63 (98) | 66 (97) | 129 (98) |
Asian | 0 | 2 (3) | 2 (2) |
Other | 1 (2) | 0 | 1 (<1) |
BMI, kg/m2: mean (SD) | 26.5 (6.2) | 26.8 (4.9) | 26.6 (5.6) |
EDSS: mean (SD) | 5.8 (0.9) | 5.6 (0.9) | 5.7 (0.9) |
MSWS-12v1 baseline scorea | |||
Mean (SD) | 75.9 (19.8) | 71.7 (19.3) | 73.7 (19.6) |
Median (Q1, Q3) | 81.3 (65.6, 90.6) | 75.0 (64.1, 84.9) | 78.6 (64.6, 88.0) |
(Min, max) | (8.3, 100) | (25.0, 100) | (8.3, 100) |
MSIS-29v1 physical subscale baseline scorea | |||
Mean (SD) | 53.0 (19.1) | 50.9 (19.4) | 51.9 (19.2) |
Median (Q1, Q3) | 57.5 (40.3, 65.6) | 50.0 (38.1, 67.2) | 52.5 (38.8, 66.3) |
(Min, max) | (13.1, 91.9) | (8.1, 100) | (8.1, 100) |
MSIS-29v1 psychological subscale baseline scorea | |||
Mean (SD) | 36.3 (20.0) | 36.0 (22.2) | 36.2 (21.1) |
Median (Q1, Q3) | 34.0 (22.9, 47.2) | 32.6 (18.1, 50.7) | 33.3 (20.8, 49.3) |
(Min, max) | (0.0, 93.1) | (1.4, 90.3) | (0.0, 93.1) |
EQ-5D-5L baseline (day 1) utility score | |||
Mean (SD) | 0.51 (0.23) | 0.54 (0.20) | 0.52 (0.21) |
Median (Q1, Q3) | 0.55 (0.39, 0.69) | 0.58 (0.46, 0.70) | 0.57 (0.42, 0.69) |
(Min, max) | (−0.19, 1.00) | (0.04, 0.85) | (−0.19, 1.00) |
Baseline scores calculated as the mean of screening and day 1 scores.
BID: twice daily; BMI: body mass index.