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Efficacy of prolong...
Efficacy of prolonged-release fampridine versus placebo on walking ability, dynamic and static balance, physical impact of multiple sclerosis, and quality of life: an integrated analysis of MOBILE and ENHANCE
- Article/chapterEnglish2022
Publisher, publication year, extent ...
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2022-05-18
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SAGE Publications,2022
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LIBRIS-ID:oai:gup.ub.gu.se/321161
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https://gup.ub.gu.se/publication/321161URI
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https://doi.org/10.1177/17562864221090398DOI
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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Background: MOBILE and ENHANCE were similarly designed randomized trials of walking-impaired adults with relapsing-remitting or progressive multiple sclerosis (MS) who received placebo or 10 mg prolonged-release (PR)-fampridine twice daily for 24 weeks. Both studies showed sustained and clinically meaningful improvement in broad measures of walking and balance over 24 weeks of PR-fampridine treatment. Objective: To evaluate the functional benefits and safety of PR-fampridine versus placebo using a post hoc integrated efficacy analysis of MOBILE and ENHANCE data. Methods: Data from the intention-to-treat (ITT) populations of MOBILE and ENHANCE studies were pooled in a post hoc analysis based on the following outcome measures: 12-item MS Walking Scale (MSWS-12), Timed Up and Go (TUG) speed, Berg Balance Scale (BBS), MS Impact Scale physical impact subscale (MSIS-29 PHYS), EQ-5D utility index score, visual analogue scale (VAS), and adverse events. The primary analysis was the proportion of people with MS (PwMS) with a mean improvement in MSWS-12 score (⩾8 points) from baseline over 24 weeks. A subgroup analysis based on baseline characteristics was performed. Findings: In the ITT population (N = 765; PR-fampridine, n = 383; placebo, n = 382), a greater proportion of PR-fampridine–treated PwMS than placebo-treated PwMS achieved a clinically meaningful improvement in the MSWS-12 scale over 24 weeks (44.3% versus 33.0%; p < 0.001). PR-fampridine MSWS-12 responders demonstrated greater improvements from baseline in TUG speed, BBS score, MSIS-29 PHYS score, and EQ-5D utility index and VAS scores versus PR-fampridine MSWS-12 nonresponders and placebo. Subgroup analyses based on baseline characteristics showed consistency in the effects of PR-fampridine. Conclusion: The pooled analysis of MOBILE and ENHANCE confirms previous evidence that treatment with PR-fampridine results in clinically meaningful improvements in walking, mobility and balance, self-reported physical impact of MS, and quality of life and is effective across a broad range of PwMS.
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Gasperini, C.
(author)
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Lycke, Jan,1956Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience(Swepub:gu)xlycja
(author)
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Ziemssen, T.
(author)
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Feys, P.
(author)
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Xiao, S.
(author)
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Acosta, C.
(author)
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Koster, T.
(author)
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Hobart, J.
(author)
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Göteborgs universitetInstitutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap
(creator_code:org_t)
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In:Therapeutic Advances in Neurological Disorders: SAGE Publications151756-28561756-2864
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Hupperts, R.
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Gasperini, C.
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Lycke, Jan, 1956
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Ziemssen, T.
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Feys, P.
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Xiao, S.
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Acosta, C.
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Koster, T.
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Hobart, J.
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- MEDICAL AND HEALTH SCIENCES
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and Health Sciences
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Therapeutic Adva ...
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University of Gothenburg