After years of setbacks, the perspective of neuroprotective stroke therapy has revived in light of recent study results. We outline in this review how a neuroprotective candidate drug should be developed, beginning with a thorough preclinical evaluation according to the STAIR (Stroke Therapy Academic Industry Roundtable) criteria. Assessing the safety of the candidate drug in the relatively straightforward Phase IIA would be the first step into clinical development. While advancing into Phase IIB, the implementation of a responder analysis, the use of a surrogate biomarker as well as the use of Bayesian methodology should be considered to increase the likelihood of seeing any therapeutic sign. Clinical development in Phase III should consider that previously used dichotomized endpoints appropriate for evaluation of thrombolytic drugs are likely to be insufficient for assessing efficacy of neuroprotective drugs. Detection of a clinically relevant shift in the outcome measure appears to be a more relevant approach for the type of drug that achieves a reduction and not a reverse of the ischaemic lesion.
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December 2006
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Conference Article|
October 25 2006
Perspectives on neuroprotective stroke therapy
W.-R. Schäbitz;
W.-R. Schäbitz
1
*Department of Neurology, University of Münster, Albert-Schweitzer-Strasse 33, 48129 Münster, Germany
1To whom correspondence should be addressed (email schabitz@uni-muenster.de).
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M. Fisher
M. Fisher
†Department of Neurology, University of Massachusetts, Memorial Health Care, Belmont Street, 01605 Worcester, MA, U.S.A.
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Publisher: Portland Press Ltd
Received:
June 09 2006
Online ISSN: 1470-8752
Print ISSN: 0300-5127
© 2006 The Biochemical Society
2006
Biochem Soc Trans (2006) 34 (6): 1271–1276.
Article history
Received:
June 09 2006
Citation
W.-R. Schäbitz, M. Fisher; Perspectives on neuroprotective stroke therapy. Biochem Soc Trans 1 December 2006; 34 (6): 1271–1276. doi: https://doi.org/10.1042/BST0341271
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