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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003ETreatment with prolonged-release fampridine results in sustained, clinically meaningful improvement in walking ability and balance in patients with multiple sclerosis (MS). This article presents the results of Exploratory Study to Assess the Effect of Fampridine on Walking Ability and Balance in Patients With Multiple Sclerosis (MOBILE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01597297\u0026amp;atom=%2Fspmdc%2F14%2F6%2F12.atom\u0022\u003ENCT01597297\u003C\/a\u003E), an exploratory, phase 2, randomized, double-blinded, placebo-controlled trial.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDemyelinating Diseases Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDemyelinating Diseases\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ETreatment with prolonged-release (PR) fampridine results in sustained, clinically meaningful improvement in walking ability and balance in patients with multiple sclerosis (MS), said Jan Lycke, MD, University of Gothenburg, Gothenborg, Sweden, who presented the results of Exploratory Study to Assess the Effect of Fampridine on Walking Ability and Balance in Patients With Multiple Sclerosis (MOBILE; \u003Ca href=\u0022http:\/\/ClinicalTrials.gov\u0022\u003EClinicalTrials.gov\u003C\/a\u003E identifier \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01597297\u0026amp;atom=%2Fspmdc%2F14%2F6%2F12.atom\u0022\u003ENCT01597297\u003C\/a\u003E), an exploratory, phase 2, randomized, double-blinded, placebo-controlled trial.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EAmong patients with MS, difficulty walking is a commonly reported disability that negatively affects quality of life. PR fampridine (also known as sustained- or modified-release fampridine and dalfampridine extended release) is the only drug currently approved to improve walking in patients with MS. The objective of the MOBILE study was to evaluate the effect of PR fampridine on self-assessed walking ability, dynamic and static balance, and quality of life for patients with MS.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EPatients in the MOBILE study had primary or secondary progressive MS, progressive-relapsing MS, or relapsing-remitting MS and Expanded Disability Status Scale scores of 4 to 7. Walking ability was assessed using the 12-item Multiple Sclerosis Walking Scale (MSWS-12) and the Patient Global Impression of Change scale. Mobility and balance (dynamic and static) were assessed using the Timed Up and Go (TUG) test and the Berg Balance Scale. The physical subscale of the 29-item Multiple Sclerosis Impact Scale and the EuroQol 5\u2013Dimension 5-Level instrument were used to evaluate quality of life. Clinically meaningful improvement was defines as \u22658-point mean improvement on the MSWS-12 and \u003Csup\u003E3\u003C\/sup\u003E15% mean improvement on the TUG test.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EA total of 132 patients from 24 sites were randomized to treatment with PR fampridine (10-mg tablets; n=68) or placebo (n=64) twice daily for 24 weeks. Subjects\u0027 mean age was 49.8 years, and their mean Expanded Disability Status Scale score was 5.7. About half (54%) were women. The majority of subjects had either relapsing-remitting MS (33%) or secondary progressive MS (52%).\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EOver the 24-week study, significantly more subjects randomized to PR fampridine experienced clinically meaningful improvements on the MSWS-12 (48.5% vs 28.1%, p=0.015) and TUG speed (47.1% vs 30.2%; p=0.026) versus placebo. PR fampridine treatment also resulted in greater median improvements from baseline on the MSWS-12 (\u22126.92 vs \u22122.89), the TUG speed (12.26% vs 3.49%), the Berg Balance Scale (2.93 vs 1.71), and the 29-item Multiple Sclerosis Impact Scale physical subscale (\u22124.96 vs \u22122.19) versus placebo. After discontinuation of treatment at Week 24, scores returned to baseline levels by Week 26 (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/6\/12\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Median Change From Baseline by Study Visit\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-571939766\u0022 data-figure-caption=\u0022Median Change From Baseline by Study Visit\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/6\/12\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/6\/12\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/6\/12\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15889\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EMedian Change From Baseline by Study Visit\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EBBS=Berg Balance Scale; MSIS-29 PHYS=29-item Multiple Sclerosis Impact Scale-Physical subscale; MSWS-12=12-item Multiple Sclerosos Walking Scale; PR=prolonged release; TUG=Timed Up and Go.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from I. Lycke, MD.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-3\u0022\u003E*On December 1, 2014, this was changed from Media to Median.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-8\u0022\u003EBetween-group differences in the results for the Patient Global Impression of Change were reported only at the week 2 visit but were not significant. There was no clear difference between the 2 groups on the EuroQol 5-Dimension 5-Level at any time point.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003ESafety findings were consistent with the known safety profile of PR fampridine. Nasopharyngitis was the most frequently reported adverse event in the PR fampridine group, while urinary tract infection was the most common adverse event for placebo-treated patients.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EThis study demonstrated benefits beyond those seen in the phase 3 PR fampridine studies. Potentially, that was related to this trial\u0027s longer double-blind, placebo-controlled treatment period and its broader range of objective and patient-reported measures of walking ability.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/6\/12.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzpa3q\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzpa3q\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}