Study outcomes
The primary outcome was the mean change of “intra-patient” global score of the VFQ-25 questionnaire after citicoline oral solution vs placebo at 6 months as compared with baseline. Secondary outcomes were the difference in the change from baseline at 3 and 9 months; the comparison between different time-points in each arm with the respective baseline; the comparison between the two arms at each time-point of the two study questionnaires, VFQ-25 and SF-36, and the safety and tolerability of citicoline oral solution.