{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T09:59:02Z","timestamp":1777888742941,"version":"3.51.4"},"reference-count":20,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2020,7,8]],"date-time":"2020-07-08T00:00:00Z","timestamp":1594166400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Restorative Neurology and Neuroscience"],"published-print":{"date-parts":[[2020,9,24]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Stroke-induced ischemia affects both cortex and underlying white matter. Dalfampridine extended release tablets (D-ER) enhance action potential conduction in demyelinated axons, which may positively affect post-stroke recovery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>Based on promising preliminary data, we compared efficacy of D-ER administered at 7.5\u200amg or 10\u200amg with placebo on post-stroke ambulation. Primary study outcome (response) was a \u226520% increase on the 2-minute walk test (2\u200aMinWT) at 12 weeks after first drug administration.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This was a multicenter, randomized, placebo-controlled, 3-arm, parallel-group, safety and efficacy trial. After obtaining baseline measures of 2\u200aMinWT, Walk-12, and Timed Up and Go, subjects entered a 2-week, single-blind placebo run-in period and were randomized 1:1:1 to receive 7.5\u200amg D-ER, 10\u200amg D-ER, or placebo, dosed twice-daily for 12 weeks. Follow-up evaluations occurred at weeks 14 and 16 when subjects were off study drug.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The study was terminated early with 377 of planned 540 patients enrolled, due to no treatment effect. At week 12, mean increase in distances walked in 2 minutes were similar among the 3 study groups (14.9\u00b140.0 feet; 19.4\u00b139.6 feet; and 20.4\u00b138.3 feet for placebo, 7.5\u200amg D-ER, and 10\u200amg D-ER, respectively). The proportion of subjects who showed \u226520% improvement on 2\u200aMinWT at week 12 was 13.5%, 14.0%, and 19.0%, for placebo, 7.5\u200amg D-ER, and 10\u200amg D-ER, respectively; these were nonsignificant changes from baseline for all groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>D-ER at either a 7.5-mg or 10-mg dose did not significantly increase performance on the 2\u200aMinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment. (Clinical Trial # NCT02271217).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3233\/rnn-201009","type":"journal-article","created":{"date-parts":[[2020,7,10]],"date-time":"2020-07-10T10:27:31Z","timestamp":1594376851000},"page":"301-309","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["A double-blind, randomized, controlled study of two dose strengths of dalfampridine extended release on walking deficits in ischemic stroke"],"prefix":"10.1177","volume":"38","author":[{"given":"Stephen J.","family":"Page","sequence":"first","affiliation":[{"name":"RehabLab\u2122, Neurorecovery Unlimited, LLC, Columbus, OH, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Scott E.","family":"Kasner","sequence":"additional","affiliation":[{"name":"University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcia","family":"Bockbrader","sequence":"additional","affiliation":[{"name":"Ohio State University Medical Center, Columbus, OH, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Goldstein","sequence":"additional","affiliation":[{"name":"JEM Research Institute, Atlantis, FL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seth P.","family":"Finklestein","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"MingMing","family":"Ning","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Waleed H.","family":"El-Feky","sequence":"additional","affiliation":[{"name":"Texas Neurology, Dallas, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christina A.","family":"Wilson","sequence":"additional","affiliation":[{"name":"University of Florida, Gainesville, FL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Holly","family":"Roberts","sequence":"additional","affiliation":[{"name":"Acorda Therapeutics, Inc., Ardsley, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"on behalf of all of the investigators involved in the MILESTONE 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