Dalfampridine improves slowed processing speed in multiple sclerosis patients with mild motor disability: post hoc analysis of a randomized controlled trial
Objective: To evaluate baseline characteristics predictive of improving information processing speed in multiple sclerosis (MS) and the relationship between cognitive and motor response to dalfampridine (DA) treatment. Methods: This is a post hoc analysis of a randomized, double-blind, placebo-contr...
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Published in | Therapeutic advances in neurological disorders Vol. 14; p. 17562864211011286 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
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London, England
SAGE Publications
2021
SAGE PUBLICATIONS, INC SAGE Publishing |
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Abstract | Objective:
To evaluate baseline characteristics predictive of improving information processing speed in multiple sclerosis (MS) and the relationship between cognitive and motor response to dalfampridine (DA) treatment.
Methods:
This is a post hoc analysis of a randomized, double-blind, placebo-controlled trial in patients with MS randomized to receive DA 10 mg or placebo twice daily for 12 consecutive weeks. Here, we include only data from 71 patients in the arm treated with DA. According to the median value of Symbol Digit Modalities Test (SDMT) response, patients were categorized as “full responders” (FR) or “partially responders” (PR).
Results:
There was higher possibility of being FR in the presence of a baseline lower Expanded Disability Status Scale [odds ratio (OR) 0.69; 95% confidence interval (CI) 0.5–0.97, p = 0.034], a higher Multiple Sclerosis Functional Composite value (OR 1.37; 95%CI 1.05–1.8, p = 0.022), a lower Timed 25-Foot Walk Test (OR 0.76; 95% CI 0.6–0.98, p = 0.033), and a lower 9-Hole Peg Test with dominant hand (OR 0.92; 95% CI 0.86–0.99, p = 0.029). FR group did not show any significant improvement of motor performance compared with PR group.
Conclusion:
The current analysis shows that in MS patients with cognitive deficit, the greatest improvement in SDMT provided by DA was observed in patients with milder motor impairment; cognitive and motor responses to treatments are not related.
Trial registration:
EU Clinical Trials Register; ID 2013-002558-64 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002558-64) |
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AbstractList | Objective: To evaluate baseline characteristics predictive of improving information processing speed in multiple sclerosis (MS) and the relationship between cognitive and motor response to dalfampridine (DA) treatment. Methods: This is a post hoc analysis of a randomized, double-blind, placebo-controlled trial in patients with MS randomized to receive DA 10 mg or placebo twice daily for 12 consecutive weeks. Here, we include only data from 71 patients in the arm treated with DA. According to the median value of Symbol Digit Modalities Test (SDMT) response, patients were categorized as “full responders” (FR) or “partially responders” (PR). Results: There was higher possibility of being FR in the presence of a baseline lower Expanded Disability Status Scale [odds ratio (OR) 0.69; 95% confidence interval (CI) 0.5–0.97, p = 0.034], a higher Multiple Sclerosis Functional Composite value (OR 1.37; 95%CI 1.05–1.8, p = 0.022), a lower Timed 25-Foot Walk Test (OR 0.76; 95% CI 0.6–0.98, p = 0.033), and a lower 9-Hole Peg Test with dominant hand (OR 0.92; 95% CI 0.86–0.99, p = 0.029). FR group did not show any significant improvement of motor performance compared with PR group. Conclusion: The current analysis shows that in MS patients with cognitive deficit, the greatest improvement in SDMT provided by DA was observed in patients with milder motor impairment; cognitive and motor responses to treatments are not related. Trial registration: EU Clinical Trials Register; ID 2013-002558-64 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002558-64) OBJECTIVETo evaluate baseline characteristics predictive of improving information processing speed in multiple sclerosis (MS) and the relationship between cognitive and motor response to dalfampridine (DA) treatment. METHODSThis is a post hoc analysis of a randomized, double-blind, placebo-controlled trial in patients with MS randomized to receive DA 10 mg or placebo twice daily for 12 consecutive weeks. Here, we include only data from 71 patients in the arm treated with DA. According to the median value of Symbol Digit Modalities Test (SDMT) response, patients were categorized as "full responders" (FR) or "partially responders" (PR). RESULTSThere was higher possibility of being FR in the presence of a baseline lower Expanded Disability Status Scale [odds ratio (OR) 0.69; 95% confidence interval (CI) 0.5-0.97, p = 0.034], a higher Multiple Sclerosis Functional Composite value (OR 1.37; 95%CI 1.05-1.8, p = 0.022), a lower Timed 25-Foot Walk Test (OR 0.76; 95% CI 0.6-0.98, p = 0.033), and a lower 9-Hole Peg Test with dominant hand (OR 0.92; 95% CI 0.86-0.99, p = 0.029). FR group did not show any significant improvement of motor performance compared with PR group. CONCLUSIONThe current analysis shows that in MS patients with cognitive deficit, the greatest improvement in SDMT provided by DA was observed in patients with milder motor impairment; cognitive and motor responses to treatments are not related. TRIAL REGISTRATIONEU Clinical Trials Register; ID 2013-002558-64 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002558-64). To evaluate baseline characteristics predictive of improving information processing speed in multiple sclerosis (MS) and the relationship between cognitive and motor response to dalfampridine (DA) treatment. This is a post hoc analysis of a randomized, double-blind, placebo-controlled trial in patients with MS randomized to receive DA 10 mg or placebo twice daily for 12 consecutive weeks. Here, we include only data from 71 patients in the arm treated with DA. According to the median value of Symbol Digit Modalities Test (SDMT) response, patients were categorized as "full responders" (FR) or "partially responders" (PR). There was higher possibility of being FR in the presence of a baseline lower Expanded Disability Status Scale [odds ratio (OR) 0.69; 95% confidence interval (CI) 0.5-0.97, = 0.034], a higher Multiple Sclerosis Functional Composite value (OR 1.37; 95%CI 1.05-1.8, = 0.022), a lower Timed 25-Foot Walk Test (OR 0.76; 95% CI 0.6-0.98, = 0.033), and a lower 9-Hole Peg Test with dominant hand (OR 0.92; 95% CI 0.86-0.99, = 0.029). FR group did not show any significant improvement of motor performance compared with PR group. The current analysis shows that in MS patients with cognitive deficit, the greatest improvement in SDMT provided by DA was observed in patients with milder motor impairment; cognitive and motor responses to treatments are not related. EU Clinical Trials Register; ID 2013-002558-64 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002558-64). Objective: To evaluate baseline characteristics predictive of improving information processing speed in multiple sclerosis (MS) and the relationship between cognitive and motor response to dalfampridine (DA) treatment. Methods: This is a post hoc analysis of a randomized, double-blind, placebo-controlled trial in patients with MS randomized to receive DA 10 mg or placebo twice daily for 12 consecutive weeks. Here, we include only data from 71 patients in the arm treated with DA. According to the median value of Symbol Digit Modalities Test (SDMT) response, patients were categorized as “full responders” (FR) or “partially responders” (PR). Results: There was higher possibility of being FR in the presence of a baseline lower Expanded Disability Status Scale [odds ratio (OR) 0.69; 95% confidence interval (CI) 0.5–0.97, p = 0.034], a higher Multiple Sclerosis Functional Composite value (OR 1.37; 95%CI 1.05–1.8, p = 0.022), a lower Timed 25-Foot Walk Test (OR 0.76; 95% CI 0.6–0.98, p = 0.033), and a lower 9-Hole Peg Test with dominant hand (OR 0.92; 95% CI 0.86–0.99, p = 0.029). FR group did not show any significant improvement of motor performance compared with PR group. Conclusion: The current analysis shows that in MS patients with cognitive deficit, the greatest improvement in SDMT provided by DA was observed in patients with milder motor impairment; cognitive and motor responses to treatments are not related. Trial registration: EU Clinical Trials Register; ID 2013-002558-64 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002558-64) |
Author | Pozzilli, Carlo Barbuti, Elena Gasperini, Claudio De Giglio, Laura Prosperini, Luca Tommasin, Silvia |
Author_xml | – sequence: 1 givenname: Carlo orcidid: 0000-0002-6360-4798 surname: Pozzilli fullname: Pozzilli, Carlo email: carlo.pozzilli@uniroma1.it organization: MS Center Sant’Andrea Hospital, Sapienza University of Rome, Rome, Italy – sequence: 2 givenname: Luca surname: Prosperini fullname: Prosperini, Luca organization: Department of Neuroscience San Camillo-Forlanini Hospital, Rome, Italy – sequence: 3 givenname: Silvia surname: Tommasin fullname: Tommasin, Silvia organization: Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy – sequence: 4 givenname: Claudio surname: Gasperini fullname: Gasperini, Claudio organization: Department of Neuroscience San Camillo-Forlanini Hospital, Rome, Italy – sequence: 5 givenname: Elena surname: Barbuti fullname: Barbuti, Elena organization: MS Center Sant’Andrea Hospital, Sapienza University of Rome, Rome, Italy – sequence: 6 givenname: Laura surname: De Giglio fullname: De Giglio, Laura organization: Medicine Department, Neurology Unit San Filippo Neri Hospital, Rome, Italy |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/34035835$$D View this record in MEDLINE/PubMed |
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Keywords | response to treatment dalfampridine multiple sclerosis processing speed |
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fullname: Goretti – volume: 20 start-page: 844 year: 2018 end-page: 850 article-title: Is impaired information processing speed a matter of structural or functional damage in MS? publication-title: Neuroimage Clin contributor: fullname: Eijlers – volume: 10 start-page: 1 year: 2019 end-page: 11 article-title: Nonwalking response to fampridine in patients with multiple sclerosis in a real-world setting publication-title: Ther Adv Chronic Dis contributor: fullname: Akgün – volume: 264 start-page: 2436 year: 2017 end-page: 2449 article-title: Efficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsing-remitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study) publication-title: J Neurol contributor: fullname: Rocca – volume: 26 start-page: 233 year: 2020 end-page: 244 article-title: Imaging correlates of hand motor performance in multiple sclerosis: a multiparametric structural and 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Validity of the symbol digit modalities test as a cognition performance outcome measure for multiple sclerosis publication-title: Mult Scler contributor: fullname: Phillips – volume: 34 start-page: 599 year: 2020 end-page: 628 article-title: Cognitive efficacy of pharmacologic treatments in multiple sclerosis: a systematic review publication-title: CNS drugs contributor: fullname: Genova – volume: 265 start-page: 809 year: 2018 end-page: 816 article-title: Cerebellum and cognition in multiple sclerosis: the fall status matters publication-title: J Neurol contributor: fullname: Achiron – ident: bibr3-17562864211011286 doi: 10.1007/s00415-015-7797-1 – ident: bibr8-17562864211011286 doi: 10.1016/j.jns.2016.08.052 – ident: bibr27-17562864211011286 doi: 10.1212/WNL.0000000000003656 – ident: bibr11-17562864211011286 doi: 10.1007/s13311-019-00813-5 – ident: bibr29-17562864211011286 doi: 10.1212/01.wnl.0000326213.89576.0e – ident: bibr9-17562864211011286 doi: 10.1016/j.msard.2016.10.011 – ident: bibr25-17562864211011286 doi: 10.1093/brain/awaa062 – ident: bibr16-17562864211011286 doi: 10.1002/ana.22366 – ident: bibr35-17562864211011286 doi: 10.1016/j.nicl.2018.05.015 – ident: bibr13-17562864211011286 doi: 10.1212/WNL.0000000000007970 – ident: bibr1-17562864211011286 doi: 10.1002/ana.22240 – ident: bibr21-17562864211011286 doi: 10.1007/s10072-013-1558-7 – ident: bibr20-17562864211011286 doi: 10.1080/13854046.2012.668220 – ident: bibr10-17562864211011286 doi: 10.1007/s00415-018-8796-9 – ident: bibr26-17562864211011286 doi: 10.1016/j.jns.2016.06.019 – ident: bibr18-17562864211011286 doi: 10.1007/s00415-017-8642-5 – ident: bibr2-17562864211011286 doi: 10.1016/S0140-6736(09)60442-6 – ident: bibr14-17562864211011286 doi: 10.1007/s40263-020-00734-4 – ident: bibr32-17562864211011286 doi: 10.1177/1352458518822145 – ident: bibr15-17562864211011286 doi: 10.1177/1352458517690821 – ident: bibr12-17562864211011286 doi: 10.1177/2040622319835136 – ident: bibr37-17562864211011286 doi: 10.1007/s00415-018-8774-2 – ident: bibr5-17562864211011286 doi: 10.1016/j.jns.2015.11.035 – ident: bibr33-17562864211011286 doi: 10.1371/journal.pone.0146080 – ident: bibr6-17562864211011286 doi: 10.1177/1352458515606809 – ident: bibr38-17562864211011286 doi: 10.1177/1352458517701313 – ident: bibr23-17562864211011286 doi: 10.1177/1352458509106212 – ident: bibr30-17562864211011286 doi: 10.1016/j.nicl.2018.09.021 – ident: bibr28-17562864211011286 doi: 10.1016/j.jns.2020.116978 – ident: bibr34-17562864211011286 doi: 10.1177/1352458518788218 – ident: bibr4-17562864211011286 doi: 10.1177/1352458515581436 – volume-title: Beck depression inventory-II: Manuale italiano year: 2006 ident: bibr19-17562864211011286 contributor: fullname: Ghisi M – ident: bibr7-17562864211011286 doi: 10.3233/NRE-161361 – ident: bibr31-17562864211011286 doi: 10.1007/s00415-018-9075-5 – volume-title: A manual for the brief repeatable battery of neuropsychological tests in multiple sclerosis year: 1990 ident: bibr22-17562864211011286 contributor: fullname: Rao SM – ident: bibr24-17562864211011286 doi: 10.1136/jnnp-2013-306860 – ident: bibr36-17562864211011286 doi: 10.1177/1352458519837707 – ident: bibr17-17562864211011286 doi: 10.1177/1352458506070933 |
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To evaluate baseline characteristics predictive of improving information processing speed in multiple sclerosis (MS) and the relationship between... To evaluate baseline characteristics predictive of improving information processing speed in multiple sclerosis (MS) and the relationship between cognitive and... Objective: To evaluate baseline characteristics predictive of improving information processing speed in multiple sclerosis (MS) and the relationship between... OBJECTIVETo evaluate baseline characteristics predictive of improving information processing speed in multiple sclerosis (MS) and the relationship between... |
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SubjectTerms | Clinical trials Cognitive ability Double-blind studies Information processing Motor task performance Multiple sclerosis Original Research Patients Placebos Processing speed |
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Title | Dalfampridine improves slowed processing speed in multiple sclerosis patients with mild motor disability: post hoc analysis of a randomized controlled trial |
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