Abstract | OBJECTIVE: 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.
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Authors | M A van der Bruggen, H B Huisman, H Beckerman, F W Bertelsmann, C H Polman, G J Lankhorst |
Journal | Journal of neurology
(J Neurol)
Vol. 248
Issue 8
Pg. 665-71
(Aug 2001)
ISSN: 0340-5354 [Print] Germany |
PMID | 11569894
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
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Chemical References |
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Topics |
- 4-Aminopyridine
(adverse effects, therapeutic use)
- Adult
- Aged
- Chronic Disease
- Cross-Over Studies
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Sensory Thresholds
(drug effects)
- Spinal Cord Injuries
(drug therapy)
- Treatment Outcome
- Vibration
- Walking
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