Zusammenfassung
Schlaganfälle gehören zu den häufigsten Erkrankungen dieser Zeit. Die zahlreichen negativen klinischen Studien mit neuroprotektiven Substanzen führten zur Einführung von Empfehlungen der Stroke Therapy Academic Industry Roundtable (STAIR) für die präklinische und klinische Entwicklungsphase. Als Folge dieser verbesserten neuen Entwicklungen zeigte die erstmalig positive klinische Studie mit dem Radikalfänger NXY-059 ein ermutigendes Ergebnis (SAINT I), das sich allerdings in einer Folgestudie (SAINT II) nicht bestätigen ließ. In diesem Artikel analysieren wir kritisch die präklinische und klinische Entwicklung von Neuroprotektiva für die Schlaganfallbehandlung am Beispiel von NXY-059 und geben Empfehlungen für die mögliche zukünftige Entwicklung neuroprotektiver Substanzen.
Summary
Stroke remains one of the most urgent medical problems of our times. The failure of most neuroprotective drugs in clinical trials led to the initiation of the Stroke Therapy Academic Industry Roundtable guidelines. Due to this improvement, the positive clinical trial results with the free radical scavenger NXY-059 (SAINT I) was encouraging. However, the subsequent SAINT II trial did not confirm these results. In this article we critically review the history of preclinical and clinical trials based on experience of NXY-059 development and present recommendations for potential future preclinical and clinical development of neuroprotective stroke therapy.
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Interessenkonflikt
Der korrespondierende Autor weist auf folgende Beziehung/en hin: W.-R. Schäbitz ist Miterfinder einer patentierten Applikation bezüglich der neuroprotektiven Effekte von G-CSF.
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Rogalewski, A., Schäbitz, WR. Entwicklungen neuer Therapiemöglichkeiten des Schlaganfalls. Nervenarzt 79, 218–224 (2008). https://doi.org/10.1007/s00115-007-2386-x
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DOI: https://doi.org/10.1007/s00115-007-2386-x