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Title: Efficacy of three neuroprotective drugs in secondary progressive multiple sclerosis (MS-SMART): a phase 2b, multiarm, double-blind, randomised placebo-controlled trial
Author: Chataway, Jeremy
Angelis, Floriana de
Connick, Peter
Parker, Richard A.
Plantone, Domenico
Doshi, Anisha
John, Nevin
Stutters, Jonathan
MacManus, David
Prados Carrasco, Ferran
Barkhof, Frederik
Ourselin, Sebastien
Braisher, Marie
Ross, Moira
Cranswick, Gina
Pavitt, Sue H.
Giovannoni, Gavin
Gandini Wheeler-Kingshott, Claudia
Hawkins, Clive
Sharrack, Basil
Bastow, Roger
Weir, Christopher J.
Stallard, Nigel
Chandran, Siddharthan
Others: Universitat Oberta de Catalunya (UOC)
Keywords: secondary progressive multiple sclerosis
neuroprotective drugs
Issue Date: Mar-2020
Publisher: The Lancet Neurology
Citation: Chataway, J., De Angelis, F., Connick, P., Parker, R.A., Plantone, D., Doshi, A., John, N., Stutters, J., MacManus, D., Prados Carrasco, F., Barkhof, F., Ourselin, S., Braisher, M., Ross, M., Cranswick, G., Pavitt, S.H., Giovannoni, G., Gandini Wheeler-Kingshott, C.A., Hawkins, C., Sharrack, B., Bastow, R., Weir, C.J., Stallard, N. & Chandran, S. (2020). Efficacy of three neuroprotective drugs in secondary progressive multiple sclerosis (MS-SMART): a phase 2b, multiarm, double-blind, randomised placebo-controlled trial. The Lancet Neurology, 19(3), 214-225. doi: 10.1016/S1474-4422(19)30485-5
Project identifier: info:eu-repo/grantAgreement/info:eu-repo/grantAgreement/11/30/11
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Abstract: Neurodegeneration 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. Methods: We 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, age, EDSS score at randomisation, and trial site. Capsules were identical in appearance to achieve masking. Patients, investigators, and MRI readers were unaware of treatment allocation. The primary outcome measure was volumetric MRI percentage brain volume change (PBVC) from baseline to 96 weeks, analysed using multiple regression, adjusting for baseline normalised brain volume and minimisation criteria. The primary analysis was a complete-case analysis based on the intention-to-treat population (all patients with data at week 96). This trial is registered with, NCT01910259.
Language: English
ISSN: 1474-4422MIAR
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