Evaluation of dalfampridine extended release 5 and 10 mg in multiple sclerosis: A randomized controlled trial

Robert Yapundich, Angela Applebee, Francois Bethoux, Myla D. Goldman, George J. Hutton, Michele Mass, Gabriel Pardo, Michael Klingler, Herbert R. Henney, Andrew R. Blight, Enrique J. Carrazana

Research output: Contribution to journalArticle

9 Scopus citations

Abstract

Background: Dalfampridine extended-release (ER) tablets, 10 mg twice daily, have been shown to improve walking in people with multiple sclerosis. We evaluated the safety and efficacy of dalfampridine-ER 5 mg compared with 10 mg. Methods: Patients were randomized to double-blind treatment with twice-daily dalfampridine-ER tablets, 5 mg (n = 144) or 10 mg (n = 143), or placebo (n = 143) for 4 weeks. Primary efficacy endpoint was change from baseline walking speed by the Timed 25-Foot Walk 3 to 4 hours after the last dose. At 40% of sites, 2-week change from baseline walking distance was measured by the 6-Minute Walk test. Results: At 4 weeks, walking speed changes from baseline were 0.363, 0.423, and 0.478 ft/s (placebo, dalfampridine-ER 5 mg, and dalfampridine-ER 10 mg, respectively [P = NS]). Post hoc analysis of average changes between pretreatment and on-treatment showed that relative to placebo, only dalfampridine-ER 10 mg demonstrated a significant increase in walking speed (mean ± SE): 0.443 ± 0.042 ft/s versus 0.303 ± 0.038 ft/s (P = .014). Improvement in 6-Minute Walk distance was significantly greater with dalfampridine-ER 10 mg (128.6 ft, P = .014) but not with 5 mg (76.8 ft, P = .308) relative to placebo (41.7 ft). Adverse events were consistent with previous studies. No seizures were reported. Conclusions: Dalfampridine-ER 5 and 10 mg twice daily did not demonstrate efficacy on the planned endpoint. Post hoc analyses demonstrated significant increases in walking speed relative to placebo with dalfampridine-ER 10 mg. No new safety signals were observed.

Original languageEnglish (US)
Pages (from-to)138-145
Number of pages8
JournalInternational Journal of MS Care
Volume17
Issue number3
DOIs
StatePublished - 2015

ASJC Scopus subject areas

  • Clinical Neurology
  • Advanced and Specialized Nursing

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    Yapundich, R., Applebee, A., Bethoux, F., Goldman, M. D., Hutton, G. J., Mass, M., Pardo, G., Klingler, M., Henney, H. R., Blight, A. R., & Carrazana, E. J. (2015). Evaluation of dalfampridine extended release 5 and 10 mg in multiple sclerosis: A randomized controlled trial. International Journal of MS Care, 17(3), 138-145. https://doi.org/10.7224/1537-2073.2014-040