Randomized trial of 4-aminopyridine in patients with chronic incomplete spinal cord injury.
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) microm) than patients receiving placebo (mean decrease in VPT of 0.05 (0.35) microm) (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.
van der Bruggen
M A
MA
Department of Rehabilitation Medicine, University Hospital Vrije Universiteit Amsterdam, The Netherlands. h.beckerman@azvu.nl
Huisman
H B
HB
Beckerman
H
H
Bertelsmann
F W
FW
Polman
C H
CH
Lankhorst
G J
GJ
D015761:4-Aminopyridine / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012684:Sensory Thresholds / Q000187:drug effects; D013119:Spinal Cord Injuries / Q000188:drug therapy*; D016896:Treatment Outcome; D014732:Vibration; D016138:Walking
D015761:4-Aminopyridine