Randomized trial of 4-aminopyridine in patients with chronic incomplete spinal cord injury |
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Authors: | van der Bruggen M A Huisman H B Beckerman H Bertelsmann F W Polman C H Lankhorst G J |
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Institution: | (1) Department of Neurology, Amstelveen Ziekenhuis, The Netherlands, NL;(2) Department of Neurology, University Hospital Vrije Universiteit Amsterdam, The Netherlands, NL;(3) Department of Rehabilitation Medicine, University Hospital Vrije Universiteit Amsterdam, P. O. Box 7057, 1007 MB Amsterdam, The Netherlands Tel.: +31-20-4440763 Fax: +31-20-4440787 e-mail: h.beckerman@azvu.nl, NL |
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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.
Received: 13 June 2000 / Received in revised form: 9 January 2001 / Accepted: 30 January 2001 |
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Keywords: | Spinal cord injuries 4-aminopyridine Cross-over studies |
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