Two phase 3, multicenter, randomized, placebo-controlled clinical trials of fampridine-SR for treatment of spasticity in chronic spinal cord injury

D. D. Cardenas, J. F. Ditunno, V. Graziani, A. B. McLain, D. P. Lammertse, P. J. Potter, M. S. Alexander, R. Cohen, A. R. Blight

Research output: Contribution to journalArticle

24 Scopus citations

Abstract

Study design:Two randomized, double-blind, placebo-controlled trials.Objective:To evaluate the efficacy and safety of fampridine sustained-release tablets (fampridine-SR) 25 mg twice daily for moderate-to-severe spasticity in patients with chronic spinal cord injury (SCI).Setting:United States and Canada.Methods:Patients with incomplete chronic SCI were randomized to twice daily fampridine-SR 25 mg or placebo, with a 2-week single-blind placebo run-in, a 2-week titration, 12 weeks of stable dosing, 2 weeks of downward titration and 2 weeks of untreated follow-up. Co-primary end points were the change from baseline, averaged over the double-blind treatment period, for Ashworth score (bilateral knee flexors and extensors) and a 7-point Subject Global Impression of treatment (SGI; 1, terrible; 7, delighted). Secondary end points were: Penn Spasm Frequency Scale; the motor/sensory score from the International Standards for Neurological Classification of SCI; Clinician's Global Impression of Change of neurological status; and the International Index of Erectile Function (men) or the Female Sexual Function Index (women).Results:The populations were 212 and 203 patients in the two studies, respectively. Changes from baseline in Ashworth score were -0.15 (placebo) and -0.19 (fampridine-SR) in the first study, and -0.16 (placebo) and -0.28 (fampridine-SR) in the second study. The between-treatment difference was not significant for either the Ashworth score or the SGI and, with few exceptions, neither were the secondary end points. Fampridine-SR was generally well tolerated; treatment-emergent adverse events (TEAEs) and serious TEAEs were reported with similar frequency between treatments.Conclusion:Fampridine-SR was well tolerated. No significant differences were observed between treatment groups for the primary end points of Ashworth score and SGI.

Original languageEnglish (US)
Pages (from-to)70-76
Number of pages7
JournalSpinal Cord
Volume52
Issue number1
DOIs
StatePublished - Jan 1 2014

Keywords

  • 4-aminopyridine
  • dalfampridine
  • fampridine
  • sexual function
  • spasticity
  • spinal cord injuries

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

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    Cardenas, D. D., Ditunno, J. F., Graziani, V., McLain, A. B., Lammertse, D. P., Potter, P. J., Alexander, M. S., Cohen, R., & Blight, A. R. (2014). Two phase 3, multicenter, randomized, placebo-controlled clinical trials of fampridine-SR for treatment of spasticity in chronic spinal cord injury. Spinal Cord, 52(1), 70-76. https://doi.org/10.1038/sc.2013.137