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- E. Bernd Ringelstein
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Vincent Thijs
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Bo Norrving
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Angel Chamorro
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Franz Aichner
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Martin Grond
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Jeff Saver
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Rico Laage
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Armin Schneider
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Frank Rathgeb
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Gerhard Vogt
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Gabriele Charissé
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Jochen B. Fiebach
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Stefan Schwab
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Wolf R. Schäbitz
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Rainer Kollmar
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Marc Fisher
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Miroslav Brozman
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- David Skoloudik
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Franz Gruber
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Joaquin Serena Leal
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Roland Veltkamp
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Martin Köhrmann
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
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- Jörg Berrouschot
- From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
書誌事項
- タイトル別名
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- Results of the AX200 for Ischemic Stroke Trial
説明
<jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>Granulocyte colony–stimulating factor (G-CSF; AX200; Filgrastim) is a stroke drug candidate with excellent preclinical evidence for efficacy. A previous phase IIa dose–escalation study suggested potential efficacy in humans. The present large phase IIb trial was powered to detect clinical efficacy in acute ischemic stroke patients.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p> G-CSF (135 µg/kg body weight intravenous over 72 hours) was tested against placebo in 328 patients in a multinational, multicenter, randomized, and placebo-controlled trial (NCT00927836; <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="www.clinicaltrial.gov">www.clinicaltrial.gov</jats:ext-link> ). Main inclusion criteria were ≤9-hour time window after stroke onset, infarct localization in the middle cerebral artery territory, baseline National Institutes of Health Stroke Scale score range of 6 to 22, and baseline diffusion-weighted imaging lesion size ≥15 mL. Primary and secondary end points were the modified Rankin scale score and the National Institutes of Health Stroke Scale score at day 90, respectively. Data were analyzed using a prespecified model that adjusted for age, National Institutes of Health Stroke Scale score at baseline, and initial infarct volume (diffusion-weighted imaging). </jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p>G-CSF treatment failed to meet the primary and secondary end points of the trial. For additional end points such as mortality, Barthel index, or infarct size at day 30, G-CSF did not show efficacy either. There was, however, a trend for reduced infarct growth in the G-CSF group. G-CSF showed the expected peripheral pharmacokinetic and pharmacodynamic profiles, with a strong increase in leukocytes and monocytes. In parallel, the cytokine profile showed a significant decrease of interleukin-1.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>G-CSF, a novel and promising drug candidate with a comprehensive preclinical and clinical package, did not provide any significant benefit with respect to either clinical outcome or imaging biomarkers.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT00927836. </jats:p> </jats:sec>
収録刊行物
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- Stroke
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Stroke 44 (10), 2681-2687, 2013-10
Ovid Technologies (Wolters Kluwer Health)