Citicoline Stroke Trial Does Not Achieve Primary Clinical Endpoint
BusinessWire, 01/10/2000 08:12
LEXINGTON, Mass.--(BW HealthWire)--Jan. 10, 2000--Interneuron Pharmaceuticals, Inc. (NASDAQ:IPIC) today announced that a preliminary analysis of an 899-patient Phase 3 clinical trial with citicoline failed to meet its primary endpoint, a measure of improvement in neurological function among patients suffering from moderate to severe ischemic stroke. The double blind, placebo controlled trial, known as ECCO 2000 (Effects of Citicoline on Clinical Outcome - 2000 mg), was conducted at more than 170 hospitals in the U.S. and Canada.
The pre-specified, primary outcome measurement of the trial was the comparison of the percentages of patients treated with citicoline or placebo who achieved at least a 7-point improvement on NIHSS (National Institutes of Health Stroke Scale) scores from enrollment through the combined 12-week treatment and follow-up period. Secondary outcomes included additional comparisons of neurological function and infarct volume measurements among citicoline and placebo patients at the end of the study.
Although improvement in the primary outcome measurement was not achieved, certain secondary endpoints were positive. At the end of the 12-week trial period, a statistically significantly higher proportion of citicoline-treated patients achieved complete or near-complete recovery of neurological function compared to placebo-treated patients, as measured by the Rankin Scale. Likewise, at the same time point, NIHSS scores indicated a strongly positive trend in the number of citicoline-treated patients who achieved full neurological recovery. Although not statistically significant, a higher percentage of citicoline-treated patients achieved reduction in the size of their cerebral infarct compared to placebo-treated patients. In addition, preliminary review of findings from this study indicates that there were no significant adverse safety issues associated with citicoline |
