Randomized, placebo-controlled crossover study of dalfampridine extended-release in transverse myelitis

Kateryna Schwartz, Nicholas F. Wymbs, Hwa Huang, Maureen A. Mealy, Carlos A. Pardo, Kathleen Zackowski, Michael Levy

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Dalfampridine has the potential to be effective in patients with transverse myelitis (TM) as this rare disorder shares some clinical and pathogenic similarities with multiple sclerosis. Methods: This is a randomized, double-blind, placebo-controlled crossover study of dalfampridine extended-release (D-ER, Ampyra). Sixteen adult study participants with monophasic TM confirmed by MRI were enrolled if their baseline timed 25-foot walking speed was between 5 and 60 seconds. Participants were randomized to receive 10 mg twice-daily doses of either D-ER or placebo control for eight weeks, then crossed over to the second arm of placebo or dalfampridine for eight weeks. The primary outcome measure was the timed 25-foot walk. Results: Of 16 enrolled participants, three withdrew and 13 completed the trial. Among the 13 completers, nine individuals showed an average timed walk that was faster in the D-ER arm compared to the placebo arm, but only four participants met the stricter statistical threshold to be classified as a responder. Analyses of secondary clinical outcome measures including strength, balance assessments, spasticity, and Expanded Disability Status Scale (EDSS) score showed trends toward improvement with D-ER. Conclusions: D-ER may be beneficial in TM to improve walking speed and other neurological functions.

Original languageEnglish (US)
JournalMultiple Sclerosis Journal - Experimental, Translational and Clinical
Volume3
Issue number4
DOIs
StatePublished - Oct 1 2017
Externally publishedYes

Keywords

  • 4-aminopyridine
  • 4AP
  • Ampyra
  • Dalfampridine
  • Transverse myelitis

ASJC Scopus subject areas

  • Clinical Neurology
  • Cellular and Molecular Neuroscience

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