Citicoline ECCO 2000
Phase III Trial of Citicoline 2000 mg vs Placebo
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Status:
Trial complete. Results published in November of 2001.
Purpose:
To compare the neurological function of citicoline (CerAxon) treated patients with that of placebo patients at 12 weeks following stroke.
Interventions:
Citicoline
Phosphatidylcholine precursor, membrane stabilizer (cytidyl diphosphocholine)
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Year Started:
1998
Year Finished:
1999
Year Presented:
2000
Design:
Multi-center, randomized, double-blind, palceb0-controlled efficacy trial of 899 patients.
Inclusion Criteria
Patients within 24 hours of acute ischemic stroke onset, with strokes clinically thought to be in middle cerebral artery territory and NIH Stroke Scales >= 8.
Patient Involvement:
Patients were treated with CerAxon, 2000 milligrams daily, for six weeks.
Primary Outcome:
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 Outcome:
Neurological function and infarct volume measurements among citicoline and placebo patients at the end of the study.
Results:
No significant differences between placebo and treatment in planned primary or secondary endpoints. Percent of patients with >=7 point change on NIHSS: placebo 51%, citicoline 52%. No adverse effects of citicoline.
Source of Information:
Interneuron press releases 7/7/98, 9/10/98, 12/28/99, 1/10/00.
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Web Links and Publications:
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This information last updated on: 7/28/2008
Reviewed on: 07/28/2008.
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