Hobart, Jeremy
Ziemssen, Tjalf
Feys, Peter
Linnebank, Michael
Goodman, Andrew D.
Farrell, Rachel
Hupperts, Raymond
Blight, Andrew R.
Englishby, Veronica
McNeill, Manjit
Chang, Ih
Lima, Gabriel
Elkins, Jacob
,
Clinical trials referenced in this document:
Documents that mention this clinical trial
Assessment of Clinically Meaningful Improvements in Self-Reported Walking Ability in Participants with Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III ENHANCE Trial of Prolonged-Release Fampridine
https://doi.org/10.1007/s40263-018-0586-5
Funding for this research was provided by:
Biogen
Article History
First Online: 10 December 2018
Compliance with Ethical Standards
:
: This study was funded by Biogen. Biogen provided funding for medical writing support in the development of this paper; Malcolm Darkes and Juliet Bell from Excel Scientific Solutions wrote the first draft of the manuscript based on input from authors, and Kristen DeYoung of Excel Scientific Solutions copyedited and styled the manuscript per journal requirements. Biogen reviewed and provided feedback on the paper to the authors. The authors had full editorial control of the paper, and provided their final approval of all content. The open access fee was paid by Biogen.
: Jeremy Hobart has received consulting/advisor fees, grants, honoraria, support for clinical service delivery, or research support from Acorda, Biogen, Brickell Biotech, GBT, Merck Serono, MS Society of Great Britain and Northern Ireland, Novartis, Roche, Tigercat, and Vantia; his hospital received a grant from Biogen to assist in the development of clinical service for people with MS and the university received a grant to conduct data analysis, and he received honoraria for attending PR-fampridine advisory boards and payment from Biogen for lectures on MS and PR-fampridine. Tjalf Ziemssen has received grants and personal fees from Bayer, Biogen, Genzyme, Novartis, and Teva; and personal fees from Almirall, GlaxoSmithKline, Merck, and Roche. Peter Feys has received advisory board fees from Biogen; speaker fees from Excemed and Paradigms; and fees for providing educational materials from Neurocompass. Michael Linnebank has received grants to fund a distinct study on PR-fampridine from Biogen, and support for travel and fees paid to his department for attendance at a PR-fampridine steering board. Andrew D. Goodman has received personal fees from AbbVie, Acorda, Adamas, Atara, Avanir, Bayer, Biogen, Celgene, EMD Serono, Novartis, Roche, Sanofi-Genzyme, Sun, and Teva. His institution (University of Rochester) has received research support for conducting clinical trials from Acorda, Biogen, EMD Serono, Novartis, Ono, Roche, Sanofi-Genzyme, and Teva. Rachel Farrell has received advisory fees from Biogen; consulting and principal investigator fees from Canbex; and speaker fees from Allergan PLC, GW Pharma, Merck, and Teva. Raymond Hupperts has received grants and honoraria for advisory boards from Biogen, Merck, and Sanofi-Genzyme. Andrew R. Blight was an employee of and holds stock/stock options in Acorda. Veronica Englishby, Manjit McNeill, Ih Chang, and Jacob Elkins are employees of and hold stock/stock options in Biogen. Gabriel Lima was an employee of Biogen at the time the study was conducted and the manuscript drafted; holds stock/stock options in Biogen; and is a current employee of Amgen.
: The study was conducted according to the US Code of Federal Regulations Parts 50, 54, 56, and 312 Subpart D; the International Conference on Harmonisation guideline on Good Clinical Practice (E6); the European Union Clinical Trial Directive 2001/20/EC; the principles of the Declaration of Helsinki; and, where applicable, the European Directives 2001/20 and 2005/28 in relation to conduct of clinical trials and investigational medicinal products. The trial was registered with ClinicalTrials.gov (NCT02219932).
: Written informed consent was obtained from each individual before study participation.