Interneuron citicoline NDA for stroke planned for 1997 based on secondary analysis of confirmatory trial.
Executive Summary
INTERNEURON CITICOLINE PHASE III STROKE TRIAL SHOWS EFFECT IN SECONDARY ANALYSIS of moderate-to-severe stroke patients, Interneuron CEO Glenn Cooper, MD, told a Montgomery Securities health care conference in New York City July 15. The drug did not show a statistically significant benefit in the primary endpoint of all patients as assessed by the Barthel Index of neurologic function. Cooper maintained that the primary endpoint did not show a benefit because of an unexpectedly high number of patients with mild stroke in the placebo group.
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