Table 1.
Table for CK analysis in subjects treated with 6mg/kg drisapersen.
The CK analysis results in DMD patients treated with 6mg/kg drisapersen are shown. In the Clinical Study DMD114117 (phase 2, weekly vs intermittent vs placebo, 53 subjects) the CK profile shows a trend towards a CK reduction in both trials arms with drisapersen compared to placebo. In the Clinical Study DMD114044 (phase 3, treatment vs control, 186 subjects) the CK profile in treated and placebo patients (Pivotal study) till week 48 shows a large and significant decrease. In the Clinical Study DMD 114876 (phase 2, 3 or 6 mg/kg vs placebo, 51 subjects) CK is decreasing in 6mg/kg treated patients.
Trial | Visit (week) | CK Treatment difference (IU/L) | p-value |
---|---|---|---|
DMD114876 | 24 | −1058 | 0.534 |
DMD114117 | 49 | −1736 | 0.303 |
DMD114044 | 48 | −4045 | <0.001 |