Efficacy of three neuroprotective drugs in secondary progressive multiple sclerosis (MS-SMART): a phase 2b, multiarm, double-blind, randomised placebo-controlled trial

Publication date: Available online 22 January 2020Source: The Lancet NeurologyAuthor(s): Jeremy Chataway, Floriana De Angelis, Peter Connick, Richard A Parker, Domenico Plantone, Anisha Doshi, Nevin John, Jonathan Stutters, David MacManus, Ferran Prados Carrasco, Frederik Barkhof, Sebastien Ourselin, Marie Braisher, Moira Ross, Gina Cranswick, Sue H Pavitt, Gavin Giovannoni, Claudia Angela Gandini Wheeler-Kingshott, Clive Hawkins, Basil SharrackSummaryBackgroundNeurodegeneration is the pathological substrate that causes major disability in secondary progressive multiple sclerosis. A synthesis of preclinical and clinical research identified three neuroprotective drugs acting on different axonal pathobiologies. We aimed to test the efficacy of these drugs in an efficient manner with respect to time, cost, and patient resource.MethodsWe did a phase 2b, multiarm, parallel group, double-blind, randomised placebo-controlled trial at 13 clinical neuroscience centres in the UK. We recruited patients (aged 25–65 years) with secondary progressive multiple sclerosis who were not on disease-modifying treatment and who had an Expanded Disability Status Scale (EDSS) score of 4·0–6·5. Participants were randomly assigned (1:1:1:1) at baseline, by a research nurse using a centralised web-based service, to receive twice-daily oral treatment of either amiloride 5 mg, fluoxetine 20 mg, riluzole 50 mg, or placebo for 96 weeks. The randomisation procedure included minimisation based on sex, ...
Source: The Lancet Neurology - Category: Neurology Source Type: research