High-dose human ALB (albumin) therapy is highly neuroprotective in animal models of ischaemic stroke. A recently completed 82-subject pilot-phase dose-escalation trial has shown that ALB is safe, with strong preliminary suggestions of possible efficacy. We are now proceeding to a large randomized, double-blinded, placebo-controlled multicentre trial funded by the NIH (National Institutes of Health), the ALIAS (Albumin In Acute Stroke) Phase III Trial, which is designed to ascertain definitively whether high-dose ALB therapy confers neuroprotection in subjects with acute ischaemic stroke treated within 5 h of stroke onset. The primary efficacy outcome measure is a favourable outcome, defined as an NIHSS (NIH Stroke Scale) score of 0–1 or a modified Rankin Scale score of 0–1 at 3 months post-randomization. Separate randomization (1:1) to ALB or placebo therapy will be carried out in two cohorts of 900 subjects each, one that receives standard-of-care thrombolytic therapy and the other that does not. Approx. 60 North American clinical sites will participate. Subject enrolment is expected to commence in July 2006.
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December 2006
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Conference Article|
October 25 2006
The ALIAS (ALbumin In Acute Stroke) Phase III randomized multicentre clinical trial: design and progress report
M.D. Ginsberg;
M.D. Ginsberg
1
*Department of Neurology, University of Miami Miller School of Medicine, P.O. Box 016960, Miami, FL 33101, U.S.A.
1To whom correspondence should be addressed (email mdginsberg@stroke.med.miami.edu).
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Y.Y. Palesch;
Y.Y. Palesch
†Department of Biostatistics, Bioinformatics and Epidemiology, Medical University of South Carolina, Charleston, SC, U.S.A.
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M.D. Hill;
M.D. Hill
‡Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada
§Department of Community Health Sciences, University of Calgary, Calgary, AB, Canada
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Publisher: Portland Press Ltd
Received:
June 15 2006
Online ISSN: 1470-8752
Print ISSN: 0300-5127
© 2006 The Biochemical Society
2006
Biochem Soc Trans (2006) 34 (6): 1323–1326.
Article history
Received:
June 15 2006
Citation
M.D. Ginsberg, Y.Y. Palesch, M.D. Hill, for the ALIAS Trialists; The ALIAS (ALbumin In Acute Stroke) Phase III randomized multicentre clinical trial: design and progress report. Biochem Soc Trans 1 December 2006; 34 (6): 1323–1326. doi: https://doi.org/10.1042/BST0341323
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