A randomized efficacy trial of citicoline in patients with acute ischemic stroke

Wayne Clark, Benjamin J. Williams, Kenneth A. Selzer, Richard M. Zweifler, LuAnn A. Sabounjian, Richard E. Gammans

Research output: Contribution to journalArticle

168 Scopus citations


Background and Purpose - Citicoline (cytidine-5'-diphosphocholine; CDP- choline) may reduce central nervous system ischemic injury by stabilizing cell membranes and reducing free radical generation. A previous dose- comparison trial in patients with acute stroke found that 500 mg of citicoline appeared to improve neurological outcome with minimal side effects. Methods - The current trial was a 33-center, randomized, double- blind, efficacy trial in 394 patients comparing placebo (n = 127) with citicoline (n = 267) (500 mg po daily) for 6 weeks, with a 6-week posttreatment follow-up period. Patients with acute (24 hours) ischemic strokes clinically assessed to be in the middle cerebral artery territory with National Institutes of Health Stroke Scale (NIHSS) ≥5 were enrolled. Results - Mean time to treatment was 12 hours, and mean age was 71 for placebo and 70 for citicoline. Although mean baseline NIHSS were similar for both groups, there was a higher percentage of placebo patients with NIHSS 0.1. Conclusions - The results of this study indicate that citicoline was safe but ineffective in improving the outcome of patients with acute ischemic stroke who were enrolled in this trial. Post hoc analyses indicate that there may be a subgroup of patients with moderate to severe strokes who would benefit.

Original languageEnglish (US)
Pages (from-to)2592-2597
Number of pages6
Issue number12
Publication statusPublished - Dec 1999



  • Citicoline
  • Stroke
  • Treatment

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Neuroscience(all)

Cite this

Clark, W., Williams, B. J., Selzer, K. A., Zweifler, R. M., Sabounjian, L. A., & Gammans, R. E. (1999). A randomized efficacy trial of citicoline in patients with acute ischemic stroke. Stroke, 30(12), 2592-2597.