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2016 ; 47
(1
): 151-9
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Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled,
Double-Blind, Multicenter Trial
#MMPMID26564102
Muresanu DF
; Heiss WD
; Hoemberg V
; Bajenaru O
; Popescu CD
; Vester JC
; Rahlfs VW
; Doppler E
; Meier D
; Moessler H
; Guekht A
Stroke
2016[Jan]; 47
(1
): 151-9
PMID26564102
show ga
BACKGROUND AND PURPOSE: The aim of this trial was to investigate whether stroke
patients who receive Cerebrolysin show improved motor function in the upper
extremities at day 90 compared with patients who receive a placebo. METHODS: This
study was a prospective, randomized, double-blind, placebo-controlled,
multicenter, parallel-group study. Patients were treated with Cerebrolysin (30
mL/d) or a placebo (saline) once daily for 21 days, beginning at 24 to 72 hours
after stroke onset. The patients also participated in a standardized
rehabilitation program for 21 days that was initiated within 72 hours after
stroke onset. The primary end point was the Action Research Arm Test score on day
90. RESULTS: The nonparametric effect size on the Action Research Arm Test score
on day 90 indicated a large superiority of Cerebrolysin compared with the placebo
(Mann-Whitney estimator, 0.71; 95% confidence interval, 0.63-0.79; P<0.0001). The
multivariate effect size on global status, as assessed using 12 different outcome
scales, indicated a small-to-medium superiority of Cerebrolysin (Mann-Whitney
estimator, 0.62; 95% confidence interval, 0.58-0.65; P<0.0001). The rate of
premature discontinuation was <5% (3.8%). Cerebrolysin was safe and well
tolerated. CONCLUSIONS: Cerebrolysin had a beneficial effect on function and
global outcome in early rehabilitation patients after stroke. Its safety was
comparable with that of the placebo, suggesting a favorable benefit/risk ratio.
Because this study was exploratory and had a relatively small sample size, the
results should be confirmed in a large-scale, randomized clinical trial. CLINICAL
TRIAL REGISTRATION: URL: http://www.clinicaltrialsregister.eu. Unique identifier:
2007-000870-21.
|*Recovery of Function/drug effects
[MESH]
|Aged
[MESH]
|Amino Acids/pharmacology/*therapeutic use
[MESH]
|Double-Blind Method
[MESH]
|Female
[MESH]
|Humans
[MESH]
|Male
[MESH]
|Middle Aged
[MESH]
|Neuroprotective Agents/pharmacology/*therapeutic use
[MESH]