Table 1:
Baseline Demographics and Clinical Characteristics by Treatment Group
| Characteristic | Placebo (n = 117) | Ibudilast (n = 114) |
|---|---|---|
| Age — yrα | 58.5 (53.7 – 61.8) | 55.8 (50.9 – 60.4) |
| Female sex — no. (%) | 67 (57) | 59 (52) |
| Hispanic ethnic group — no. (%) | 4 (3.4) | 4 (3.5) |
| Disease duration — yrα | 14.8 (23.6 – 23.6) | 15.4 (8.9 – 23.4) |
| Primary Progressive disease — no. (%) | 62 (53) | 58 (51) |
| Expanded disability status scale1α | 6.0 (4.0 – 6.0) | 6.0 (4.5 – 6.0) |
| Timed 25-ft walk — secα | 9.9 (7.0 – 15.6) | 9.3 (6.9 – 15.0) |
| 9-Hole peg test — secα | 30.3 (25.8 – 41.5) | 28.6 (24.0 – 36.8) |
| Symbol digit modalities test2 — no. of correct answers | 41.83 ± 14.31 | 43.67 ± 14.53 |
| Low-contrast visual acuity test3 — no. of correct answersα | 30.0 (20.0 – 35.0) | 31.0 (24.0 – 39.0) |
| Multiple sclerosis functional composite score4α | −0.001 (−0.489 – 0.484) | 0.166 (−0.448 – 0.621) |
| Brain parenchymal fraction5α | 0.81 (0.79 – 0.82) | 0.81 (0.80 – 0.82) |
| Grey matter fraction5 | 0.46 ± 0.02 | 0.46 ± 0.02 |
| White matter fraction5α | 0.35 (0.33 – 0.36) | 0.35 (0.33 – 0.36) |
| T2 lesion volumeα — cm3 | 5.15 (2.24 – 16.01) | 6.60 (2.13–13.91) |
| Total intracranial volume — 10−6 mm2 | 10.8 ± 1.1 | 10.9 ± 1.1 |
| Normalized ventricular volumeα— scaled by 102 | 3.9 (3.2 – 5.1) | 3.9 (3.1 – 5.3) |
| Normalized thalamic volumeα— scaled by 103 | 9.9 (8.9 – 10.5) | 9.8 (9.0 – 10.4) |
Median (IQR) shown for variables with non-Gaussian distributions. Mean ± SD reported for Gaussian distributions. P-value for continuous variables computed using Student’s T-test. Wilcoxon Rank Sum test used for continuous variables with non-Gaussian distributions. Ventricular volume and thalamic volume normalized for head size using intracranial volume. P-value for Hispanic ethnic group computed using Fisher’s exact test. P > 0.05 for all variables except for age (p = 0.04).
indicates non-Gaussian distribution.
Scores on Expanded disability status scale (EDSS) range from 0–10 in 0.5 point increments, with higher score indicating greater disability.
Scores on the Symbol digit modalities test range from 0–110 with higher scores indicating higher performance.
Scores on the low-contrast visual acuity test range from 0–60 with higher scores indicating greater ability to read letters on a 2.5% low-contrast eye chart.
Multiple sclerosis functional composite score is a cumulative z-score ranging from −1 to 1 with 0 indicating function at the level of the baseline mean of all participants.
Brain parenchymal fraction, gray matter fraction, and white matter fraction are measures of brain size, gray matter, and white matter, respectively, relative to the outer surface contour of the brain.