Wolff, Andreas W.
Peine, Jörg
Höfler, Josef
Zurek, Gabriela
Hemker, Claus
Lingor, Paul http://orcid.org/0000-0001-9362-7096
Funding for this research was provided by:
Else Kröner-Fresenius-Stiftung/ForTra GmbH (2017_T05)
Technische Universität München
Article History
Accepted: 9 February 2024
First Online: 28 February 2024
Declarations
:
: Open Access funding enabled and organized by CAUL and its Member Institutions.This study was funded by Else Kröner-Fresenius-Stiftung/ForTra GmbH under grant no. 2017_T05 to Paul Lingor. This project has been supported by the Bundesministerium für Bildung und Forschung (BMBF), grant no. 01GM1704A, 01GM1704B, the Schweizer Nationalfonds (SNF), grant no. 32ER30 17367, and the Ministère des Affaires sociales, de la Santé et des Droits des femmes (DGOS), grant no. DGOS2016-SERI E-RARE under the frame of E-Rare-3, the ERA-Net for Research on Rare Diseases.
: Paul Lingor is an inventor on a patent for the use of Fasudil for the treatment of amyotrophic lateral sclerosis (EP 2825175 B1, US 9.980,972 B2). Gabriela Zurek heads the LC-MS/MS department of the Medical Laboratory Bremen, where the determination of total fasudil and hydroxyfasudil was performed. All other authors declare that there are no conflicts of interest.
: The approval of both, the ethics committee (no. PVN7203) and the German Federal Institute for Drugs and Medical Devices (BfArM) were obtained prior to the start of the clinical trial and the study was performed in accordance with good clinical practice and the Declaration of Helsinki.
: All participants signed an informed consent form as evidence of consent.
: Not applicable.
: Data are available from the corresponding author upon reasonable request.
: Not applicable.
: Paul Lingor developed the trial concept. Paul Lingor, Claus Hemker, and Jörg Peine wrote the trial protocol. Jörg Peine coordinated the trial execution. Josef Höfler detailed the statistical aspects of the study in the study protocol. Josef Höfler and Andreas Wolff performed the statistical analysis. Gabriela Zurek was responsible for the pharmacokinetic analyses. Andreas Wolff and Paul Lingor interpreted the study results. Andreas Wolff wrote the manuscript. All authors critically reviewed the manuscript. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.