The Effects of Lifarizine in Acute Cerebral Infarction: A Pilot Safety Study
- 1 January 1996
- journal article
- Published by S. Karger AG in Cerebrovascular Diseases
- Vol. 6 (3) , 156-160
- https://doi.org/10.1159/000108016
Abstract
Background and Purpose: Lifarizine is a novel ion channel modulator which is neuroprotective in experimental global and focal ischemia, at doses that have minimal systemic vascular effects. This was a preliminary efficacy and safety study of lifarizine in human stroke. Methods: In a multicenter, randomized, double-blind, parallel-group study, subjects with symptoms and signs of first ischemic stroke were randomized to receive lifarizine (250 µg/kg, i.v. stat. plus 60 mg b.d. orally for 5 days) or matching placebo, after stratification for age (21–74 or ≥: 75 years) and for time since stroke onset (Results: Of 147 patients recruited, 117 were evaluated for efficacy analysis. Lifarizine was well tolerated; a single seizure was attributed to active treatment. Biochemical and hematological indices were unchanged. Blood pressure fell over the study period, particularly in the lifarizine group. All-patient mortality during the 3-month study was 12/75 (16%) for lifarizine and 17/72 (24%) for placebo; amongst evaluable patients, mortality was 9/63 (14%) for lifarizine and 13/54 (24%) for placebo. At 13 weeks, the improvement in functional independence in the lifarizine group versus the placebo group was 16% greater by the Rankin Scale, p = 0.52, and 11% greater by the Barthel score, p = 0.55. Conclusions: Lifarizine was well tolerated. Mortality and functional assessment data showed favorable trends. Further studies are justified to examine the efficacy of lifarizine in acute stroke.Keywords
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