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The ALIAS (ALbumin In Acute Stroke) Phase III randomized multicentre clinical trial: design and progress report
M D Ginsberg1, Y Y Palesch, M D Hill
1Department of Neurology, University of Miami Miller School of Medicine, P.O. Box 016960, Miami, FL 33101, USA. mdginsberg@stroke.med.miami.edu
Biochemical Society Transactions
|November 1, 2006
Summary
High-dose albumin (ALB) therapy shows promise for neuroprotection in acute ischemic stroke patients. A large Phase III trial will definitively assess ALB
Area of Science:
- Neurology
- Clinical Trials
- Biomedical Research
Background:
- High-dose human albumin (ALB) demonstrates significant neuroprotection in animal models of ischemic stroke.
- A pilot study confirmed the safety of ALB therapy and suggested potential efficacy in stroke patients.
Purpose of the Study:
- To definitively ascertain if high-dose ALB therapy confers neuroprotection in acute ischemic stroke.
- To evaluate ALB efficacy in patients treated within 5 hours of stroke onset.
Main Methods:
- A large, randomized, double-blinded, placebo-controlled, multicenter Phase III trial (ALIAS Trial).
- Two cohorts (n=900 each): one receiving standard thrombolytic therapy, the other not.
- Primary outcome: favorable outcome (NIHSS or modified Rankin Scale score of 0-1 at 3 months).
Main Results:
- Pilot study indicated ALB is safe with preliminary efficacy signals.
- Phase III trial enrollment to commence July 2006 across ~60 North American sites.
Conclusions:
- High-dose ALB therapy is being investigated as a potential neuroprotective treatment for acute ischemic stroke.
- The ALIAS Phase III trial is designed to provide definitive evidence of ALB's efficacy and safety.
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