Table 2. Results for the primary and secondary outcome measures
Outcome measures Baseline* group median average ± SD Treatment* group median average ± SD P value % improvement
Primary outcome measures: brain MRI
    Number of new CEL 1.38 0.75 P = 0.004
2.92 ± 3.16 0.63 ± 0.48 78.42%
    Number of total CEL 1.50 1.00 P = 0.002
3.58 ± 3.95 1.06 ± 1.22 70.39%
Secondary outcome measures: brain MRI
    Volume of CEL (GdLV) 0.121 0.043 P = 0.014
0.231 ± 0.302 0.063 ± 0.080 72.72%
    Volume of T2 hyperintense lesions 4.195 3.471 NS
4.793 ± 3.554 4.654 ± 3.414 2.90%
    Volume of T1 hypointense lesions (black hole volume) 1.443 1.393 NS
1.912 ± 1.879 1.907 ± 1.980 0.26%
Secondary outcome measures: clinical measures
    Exacerbation rate (no. of exacerbations per patient/year) 2.40 0.00 P = 0.047
1.92 ± 1.78 0.37 ± 0.78 80.72%
    Kurtzke Expanded Disability Status Scale (EDSS; from 0 = best to 10 = worst) 2.94 2.72 NS
3.31 ± 1.72 3.07 ± 1.90 7.25%
    Scripps NRS (from 100 = best to 0 = worst) 74.88 85.63 P = 0.048
75.48 ± 13.79 82.54 ± 13.22 9.35%
    Ambulation index (from 0 = best to 10 = worst) 1.25 1.06 NS
1.80 ± 1.61 1.58 ± 1.45 12.22%
    Timed 25-foot walk, s (average of two attempts per each clinical visit) 4.33 4.31 NS
5.09 ± 2.13 4.86 ± 1.82 4.52%
    9-hole peg test, (s) 22.07 20.65 P = 0.006
22.96 ± 5.27 21.86 ± 5.26 4.79%
  • * For each patient, an average of 4 baseline months is compared with an average of 6.5 treatment months. MRI and clinical data collected within 28 days of IVMP therapy were disregarded and substituted by subsequent month data. The baseline and therapy periods were extended appropriately to yield full 4 months vs. 6.5 months comparison for each patient.

  • P value is based on nonparametric paired signed rank test.

  • Percentage of improvement is calculated from group averages.