Randomized Efficacy Trial of Citicoline in Patients With Acute Ischemic Stroke "Citicoline 007"

Completed

Phase 3 Results

Results

The planned primary analysis failed the proportional odds assumption and was rendered unreliable. There were no between-group differences seen on the planned secondary assessment analyses at 90 days, including the Barthel Index 95 at 12 weeks (last observation carried forward: placebo 40%; citicoline 40%) or mortality rate (placebo 18%; citicoline 17%). However, post hoc analyses in a subgroup of patients with baseline NIHSS 8 found that citicoline-treated patients were more likely to have a full recovery (Barthel 95): placebo 21%; citicoline 33%; P=0.05; whereas no difference was seen in patients with baseline NIHSS<8 (placebo 77%; citicoline 69%; P>0.1.