3.1.5. PARADIGM

PARADIGM [92] was a 24 month randomized double-blind, active-controlled, parallel group phase III study of 215 patients with RRMS between the ages of 10 and 17 years of age randomized to either daily oral FGM (107) 0.5 mg (0.25 mg for those weighing 40 kg or less), vs. IFNβ-1a 30 μg IM weekly. All patients had evidence of disease activity in the previous 2 years. The primary outcome, ARR, was 0.12 in FGM versus 0.67 in the IFNβ-1a treated patients, a relative decrease of 82% (*p* < 0.001). The mean percentage of relapse-free patients was 85.7 versus 38.8 favoring the FGM treatment arm. Secondary outcomes included the total number of new and enlarged T2 lesions, which was 4.39 in FGM versus 9.27 in IFNβ-1a treated patients, a 53% relative decrease (*p* < 0.001). The mean number of Gd+ lesions/scan was 0.44 in FGM versus 1.28 in IFNβ-1a treated patients. The mean rate in brain volume change was -0.48% in FGM versus −0.8% in IFNβ-1a treated patients.
