Table 2.
Main clinical and MRI outcome parameters after 12 months.
| Verum | Placebo | ||
|---|---|---|---|
| Patients with relapses (n) | 2 | 6 | n.s.a |
| Mean EDSS change [SE] | −0.25 [0.14] | + 0.38 [0.25] | n.s.b |
| Mean PASAT change [SE] | +3.2 [2.0] | +10.7 [3.2] | n.s.b |
| Mean TWT z-score change [SE] | +0.8 [0.1] | +0.2 [0.16] | n.s.b |
| Mean 9HPT z-score change [SE] | +0.5 [0.2] | +0.1 [0.16] | n.s.b |
| Total patients with CEL (n) | 1 | 5 | n.s.a |
| Total number of new T2w lesions (n) | +6 | +7 | n.s.b |
| Mean T2w volume change (mm3) | +306 | +828 | n.s.b |
This table displays the most relevant outcome parameters after 12 months of double blind treatment. There were no significant differences between verum and placebo groups. EDSS, expanded disability status scale; CEL, contrast enhancing lesions; n, number; n.s, not significant; PASAT, paced auditory serial addition test; TWT, timed walk test; SE, standard error; 9HPT, 9-hole peg test.
Exact Chi-Square tests.
Exact Mann Whitney U-tests.