Spinal cord atrophy as a primary outcome measure in phase II trials of progressive multiple sclerosis

Multiple Sclerosis : Clinical and Laboratory Research
Niamh CawleyOlga Ciccarelli

Abstract

To measure the development of spinal cord (SC) atrophy over 1 year in patients with progressive multiple sclerosis (PMS) and determine the sample sizes required to demonstrate a reduction in spinal cord cross-sectional area (SC-CSA) as an outcome measure in clinical trials. In total, 44 PMS patients (26 primary progressive multiple sclerosis (PPMS), 18 secondary progressive multiple sclerosis (SPMS)) and 29 healthy controls (HCs) were studied at baseline and 12 months. SC-CSA was measured using the three-dimensional (3D) fast field echo sequences acquired at 3T and the active surface model. Multiple linear regressions were used to investigate changes in imaging measurements. PPMS patients had shorter disease duration, lower Expanded Disability Status Scale (EDSS) and larger SC-CSA than SPMS patients. All patients together showed a significantly greater decrease in percentage SC-CSA change than HCs, which was driven by the PPMS. All patients deteriorated over 1 year, but no association was found between percentage SC-CSA change and clinical changes. The sample size per arm required to detect a 50% treatment effect over 1 year, at 80% power, was 57 for PPMS and 546 for SPMS. SC-CSA may become an outcome measure in trials of PPMS ...Continue Reading

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Citations

May 22, 2018·Multiple Sclerosis : Clinical and Laboratory Research·Charidimos TsagkasKatrin Parmar
Oct 19, 2017·Multiple Sclerosis : Clinical and Laboratory Research·Carmen Tur, Xavier Montalban
Oct 19, 2017·Multiple Sclerosis : Clinical and Laboratory Research·Matteo PardiniMaria Pia Sormani
Dec 30, 2017·AJNR. American Journal of Neuroradiology·F X AymerichA Rovira
Jan 13, 2018·Nature Reviews. Neurology·Carmen TurOlga Ciccarelli
Aug 7, 2019·Annals of Neurology·Marcello MocciaUNKNOWN MAGNIMS Study Group
Nov 5, 2019·Multiple Sclerosis : Clinical and Laboratory Research·Sara ColloroneOlga Ciccarelli
Jan 22, 2020·Multiple Sclerosis : Clinical and Laboratory Research·Rosa CorteseOlga Ciccarelli
Mar 7, 2020·Expert Review of Neurotherapeutics·Maria A RoccaMassimo Filippi
Apr 21, 2020·Expert Review of Neurotherapeutics·Eleonora TavazziNiels Bergsland
Jun 30, 2018·Neurology and Therapy·Maria PetraccaMatilde Inglese
Apr 6, 2019·Current Opinion in Neurology·Matteo PardiniMaria Pia Sormani
Apr 22, 2018·Current Treatment Options in Neurology·Tim SinneckerRegina Schlaeger
May 11, 2019·Proceedings of the National Academy of Sciences of the United States of America·Arman EshaghiOlga Ciccarelli
May 2, 2019·Therapeutic Advances in Neurological Disorders·Marcello MocciaOlga Ciccarelli
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Oct 16, 2019·Neurology·Maria A RoccaUNKNOWN MAGNIMS Study Group

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Software Mentioned

STEPS ( Similarity and Truth Estimation for Propagated )
SIENA ( Structural Image Evaluation , using Normalisation , of...
JIM
BET ( Brain Extraction Tool )
STEPS
SIENA
Stata

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