Randomized trial of 4-aminopyridine in patients with chronic incomplete spinal cord injury

Monique A M Van der Bruggen, Hélène B M Huisman, Heleen Beckerman*, Frits W. Bertelsmann, Chris H. Polman, Gustaaf J. Lankhorst

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Objective: To test the efficacy of 4-aminopyridine (4-AP) on functional status, walking speed and vibration perception in patients with chronic, incomplete spinal cord injury. Methods: Twenty SCI patients were randomized in a trial with a double-blind, crossover design to receive four weeks of orally administered 4-AP, followed by a two-week wash-out period and four weeks of placebo, or vice versa. The total daily dose of 4-AP during the four weeks of treatment was systematically increased to a maximum of 0.5 mg/kg body weight. Evaluation of (side-)effects took place at the beginning, after one week, and at the end of each four-week study period. Results: No significant benefit was found on functional status (COOP-WONCA). A statistically significant treatment effect was found on the vibration perception threshold (VPT) in the left fingers, during the first study period. On average, patients receiving 4-AP treatment responded less favourably (mean increase in VPT of (0.29 (0.31) μm) than patients receiving placebo (mean decrease in VPT of (0.05 (0.35) μm) (p = 0.04). Neither comfortable nor maximum walking speed altered significantly following 4-AP treatment. Conclusions: No statistically significant, functional benefit from 4-AP was found for patients in the present study. Furthermore, no support was found for the possibility that an a priory selection of responsive patients would have yielded more favourable results.

Original languageEnglish
Pages (from-to)665-671
Number of pages7
JournalJournal of Neurology
Volume248
Issue number8
DOIs
Publication statusPublished - 11 Aug 2001

Cite this

Van der Bruggen, M. A. M., Huisman, H. B. M., Beckerman, H., Bertelsmann, F. W., Polman, C. H., & Lankhorst, G. J. (2001). Randomized trial of 4-aminopyridine in patients with chronic incomplete spinal cord injury. Journal of Neurology, 248(8), 665-671. https://doi.org/10.1007/s004150170111