Table 4.
Characteristics of the MRI substudy population by treatment group and overall
| Dronabinol (n=182) | Placebo(n=91) | All(n=273) | |||
|---|---|---|---|---|---|
| Baseline age (years) | 52·4 (7·3) | 52·2 (8·1) | 52·3 (7·6) | ||
| Baseline weight (kg) | 74·3 (16·1) | 75·7 (17·5) | 74·8 (16·6) | ||
| Men | 80 (44%) | 31 (34%) | 111 (41%) | ||
| Women | 102 (56%) | 60 (66%) | 162 (59%) | ||
| Primary progressive MS | 60 (33%) | 38 (42%) | 98 (36%) | ||
| Secondary progressive MS | 122 (67%) | 53 (58%) | 175 (64%) | ||
| Baseline EDSS score (n per score) | |||||
| 4 | 14 (8%) | 6 (7%) | 20 (7%) | ||
| 4·5 | 12 (7%) | 5 (5%) | 17 (6%) | ||
| 5 | 12 (7%) | 6 (7%) | 18 (7%) | ||
| 5·5 | 8 (4%) | 3 (3%) | 11 (4%) | ||
| 6 | 95 (52%) | 47 (52%) | 142 (52%) | ||
| 6·5 | 41 (23%) | 24 (26%) | 65 (24%) | ||
| Baseline EDSS score | 6 (5·6–6) | 6 (6–6·5) | 6 (6–6) | ||
| Baseline normalised brain volume | 1422 (91·0) | 1417 (85·1) | 1420 (88·9) | ||
| Not reported | 24 (13·2) | 8 (8·8) | 32 (11·7) | ||
| Cumulative atrophy (%) | |||||
| Year 1 | −0·59% (0·95) | −0·60% (0·95) | −0·59% (0·95) | ||
| Not reported or excluded | 28 (15%) | 9 (9·9%) | 37 (13·6%) | ||
| Year 2 | −1·16% (1·33) | −1·18% (1·30) | −1·17% (1·31) | ||
| Not reported or excluded | 44 (24%) | 15 (16·5%) | 59 (21·6%) | ||
| Year 3 | −1·95% (1·51) | −1·82% (1·47) | −1·90% (1·49) | ||
| Not reported or excluded | 58 (32%) | 20 (22·0%) | 78 (28·6%) | ||
| New or enlarging T1 lesions during follow-up | |||||
| 0 | 107 (59%) | 57 (63%) | 164 (60%) | ||
| 1 | 24 (13%) | 13 (14%) | 37 (14%) | ||
| 2 | 12 (7%) | 7 (8%) | 19 (7%) | ||
| 3 | 5 (3%) | 5 (5%) | 10 (4%) | ||
| ≥4 | 13 (7%) | 3 (3%) | 16 (6%) | ||
| Not reported or excluded | 21 (12%) | 6 (7%) | 27 (10%) | ||
| New or enlarging T2 lesions during follow-up | |||||
| 0 | 101 (55%) | 51 (56%) | 152 (56%) | ||
| 1 | 22 (12%) | 16 (18%) | 38 (14%) | ||
| 2 | 11 (6%) | 3 (3%) | 14 (5%) | ||
| 3 | 7 (4%) | 4 (4%) | 11 (4%) | ||
| ≥4 | 20 (11%) | 11 (12%) | 31 (11%) | ||
| Not reported or excluded | 21 (12%) | 6 (7%) | 27 (10%) | ||
Data are mean (SD), n (%), and median (IQR). MS=multiple sclerosis. EDSS=expanded disability status scale.