Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study
Ludwig Kappos, Amit Bar-Or, Bruce AC Cree, Robert J Fox, Gavin Giovannoni, Ralf Gold, Patrick Vermersch, Douglas L Arnold, Sophie Arnould, Tatiana Scherz, Christian Wolf, Erik Wallstroem, Frank Dahlke
LANCET | ELSEVIER SCIENCE INC | Published : 2018
BACKGROUND: No treatment has consistently shown efficacy in slowing disability progression in patients with secondary progressive multiple sclerosis (SPMS). We assessed the effect of siponimod, a selective sphingosine 1-phosphate (S1P) receptor1,5 modulator, on disability progression in patients with SPMS. METHODS: This event-driven and exposure-driven, double-blind, phase 3 trial was done at 292 hospital clinics and specialised multiple sclerosis centres in 31 countries. Using interactive response technology to assign numbers linked to treatment arms, patients (age 18-60 years) with SPMS and an Expanded Disability Status Scale score of 3·0-6·5 were randomly assigned (2:1) to once daily oral..View full abstract
Awarded by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Novartis Pharma AG.The study investigators and Novartis are grateful to all of the patients in EXPAND for their participation in and commitment to the study. We thank Tobias Derfuss, Jens Kuhle, Davorka Tomic, and David Leppert for advice during the project. Davorka Tomic, Goril Karlsson, Nicolas Rouyrre, Harald Pohlmann, Tobias Derfuss, and Jens Kuhle provided input and help in the assessment, analysis, and interpretation of the data. This research was funded by Novartis Pharma AG (Basel, Switzerland). Ludwig Kappos, Christian Wolf, and Frank Dahlke wrote the first draft of this manuscript. Medical writing assistance was provided by Mark Rolfe and Kim Wager (Oxford PharmaGenesis, Oxford, UK), with input from all authors. Jane Francis (Oxford PharmaGenesis, Oxford, UK) copyedited and styled the manuscript as per the journal requirements. Their services were paid for by Novartis Pharma. Frauke Treppke (University Hospital Basel) provided secretarial assistance.