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To find out whether treatment with 4-aminopyridine is beneficial in multiple sclerosis(MS),70 patients with definite MS entered into a randomized,double-blind,placebo-controlled,cross-over trial in which they were treated with 4-aminopyridine and placebo for 12 weeks each(maximum dose,0.5mg/kg of body weight).The estimated effect of the treatment as measured with the Kurtzke expanded disability status scale,which was the main evaluation parameter,was 0.28 point(p=0.001).A significant decrease in the scale score(1.0 point or more)was encountered in 10 patients(16.4%) during oral treatment with 4-aminopyridine whereas it was not seen during placebo treatment(p<0.05).A significant subjective improvement(defined as an improvement that significantly affected the activities of normal daily life)was indicated by 18 patients(29.5%)during 4-aminopyridine occurred in a number of neurophysiological parameters.No serious side effects were encountered.However,subjective side effects such as paresthesias, dizziness,and light-headedness were frequently reported during 4- aminopyridine treatment.Analysis of subgroups revealed that there was no difference in efficacy between those patients randomized to receive 4- aminopyridine and then placebo and those randomized to receive placebo and then 4-aminopyridine or between patients with and those without subjective side effects.Especially patients with temperature-sensitive symptoms and patients characterized by having a longer duration of the disease and being in a progressive phase of the disease were likely to show clear clinical benefit. |
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aminopyridine,4
multiple sclerosis
multiple sclerosis,treatment of
treatment of neurologic disorder
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