LUB-INT-13
Lubeluzole in Ischemic Stroke
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Status:
Trial complete. Results published in November of 2000.
Purpose:
To determine the safety and efficacy of lubeluzole in treating acute stroke with an 8-hour inclusion time window.
Interventions:
Lubeluzole
Ion channel and nitric oxide blocker.
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Year Finished:
1998
Year Presented:
1999
Design:
Phase III international, multi-center, placebo-controlled trial of 1786 patients.
Inclusion Criteria
Patients within 0-6 or 6-8 hrs of onset of clinically diagnosed cerebral hemispheric stroke, European Stroke Scale Score (ESS) <70. Must be at least 18 years of age.
Exclusion Criteria
Patients >75 yrs with severe stroke, ESS < 8 for level of consciousness, clinical presentation suggesting an etiology for the acute neurological deficit other than thromboembolic stroke; a Barthel Index score of 70 as a result of a previous stroke or other disease; presence of significant cognitive or psychiatric disorder; CT scan not consistent with the clinical diagnosis of an ischemic stroke; or concurrent illness of sufficient severity that the patient’s life expectancy was <12 weeks. Additional exclusion criteria were serious ventricular arrhythmias, second- or third-degree AV block or QT interval >450 ms at the start; acute and/or uncompensated heart failure; recent acute myocardial infarction (<6 weeks); clinically significant history of alcohol or drug abuse; pregnancy; and thrombolytic therapy.
Patient Involvement:
Patients received a 1-hour loading infusion of 7.5 mg lubeluzole or placebo followed by a continuous 5-day infusion of 10 mg lubeluzole or placebo per day. Treatment continued until the patient showed complete neurological recovery, as defined by an ESS score of 100 or for a maximum of 5 days and 1 hour. A CT scan was performed before or within 24 hours after the start of trial medication. A second CT scan was performed between days 4 and 7 to help confirm the clinical diagnosis of ischemic stroke. A CT scan was also performed if the patient showed clinically significant deterioration
Primary Outcome:
Barthel Index (12 week functional status).
Secondary Outcome:
European Stroke Scale, Rankin Scale, survival time, mortality at 12 weeks.
Results:
No significant differences in any safety or efficacy endpoints.
Source of Information:
Presented at the 24th International Joint Conference on Stroke and Cerebral Circulation (February 1999). Stroke 30(1): 234. Stroke 2000 Nov;31(11):2543-51.
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Web Links and Publications:
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This information last updated on: 8/14/2008
Reviewed on: 08/14/2008.
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