ARTICLE | Clinical News

Northera droxidopa: Preliminary Phase III data

September 27, 2010 7:00 AM UTC

Top-line data from the modified intent-to-treat (mITT) population (n=160) of the double-blind, U.S. and Canadian Phase III Study 301 trial showed that Northera met the primary endpoint of significantly reducing mean composite OHQ scores from randomization to day 7 vs. placebo (1.83 vs. 0.93 points, p=0.003). The 11-point OHQ measures the severity of 6 symptoms on the orthostatic hypotension symptom assessment scale (OHSA) and 4 patient function criteria on the orthostatic hypotension daily activities scale (OHDAS). Northera also met 8 of 10 secondary endpoints by significantly improving mean scores on 4 of 6 OHSA symptoms and all 4 OHDAS symptoms vs. placebo. On the OHSA, Northera significantly reduced mean dizziness (2.4 vs. 1.1 points, p<0.001), vision (1.6 vs. 0.7 points, p=0.013), weakness (1.9 vs. 0.9 points, p=0.007) and fatigue (1.9 vs. 1.2 points, p=0.03) scores vs. placebo, but non-significantly reduced head and neck pain scores (1 vs. 0.8 points, p=0.975), with no change in concentration scores vs. placebo (0.9 points for both, p=0.355).

On the OHDAS, Northera significantly reduced mean standing short time (1.9 vs. 0.8 points, p=0.003), standing long time (2.3 vs. 1 point, p=0.001), walking short time (1.7 vs. 0.6 points, p=0.009) and walking long time vs. placebo (1.8 vs. 1.1 points, p=0.007). Northera also significantly reduced mean composite OHSA (1.68 vs. 0.95 points, p=0.01) and OHDAS (1.98 vs. 0.92 points, p=0.003) scores vs. placebo. Additionally, Northera significantly increased standing SBP by 11.2 mmHg vs. 3.9 mmHg for placebo (p<0.001). ...