Multiple Sclerosis, December 2001,
vol. 7, no. 6, pp. 354-358(5)
Previous studies suggest that aminopyridine
may play a role in the symptomatic treatment of fatigue in multiple sclerosis.
Although the mechanism underlying
the beneficial effect on fatigue remains unclear, it has been proposed
that aminopyridines may help to improve conduction in demyelinated central
pathways, implicating both axonal and synaptic mechanisms.
The objective of the present study
is to determine whether 4-AP decreases daily-living fatigue in progressive
multiple sclerosis.
The effect of 4-AP on other neurophysiological
and neuropsychological parameters was also considered.
A 'double-blind', randomized, 'placebo-controlled',
crossover trial was conducted on 54 patients with progressive multiple
sclerosis.
All patients received treatment with
placebo and 32 mg per day of 4-AP, each for 6 months.
The main outcome measure was the
Fatigue Severity Scale.
Secondary measures were EDSS, cognitive
functions and neurophysiological parameters.
Forty-nine patients (91%) completed
the study. Changes in fatigue scores, EDSS and cognitive functions were
not significantly different between 4-AP and placebo.
However, when patients treated with
4-AP were divided into two groups according to the serum level of 4-AP,
a significant effect on fatigue compared with placebo was observed in the
'high level' (>30 ng/ml) group (P=0.05).
Synchronization of motor evoked potentials
improved during 4-AP with respect to placebo (P=0.019) and this correlated
positively with fatigue reduction (P=0.010). No relevant side effects were
observed.
© 2002 ingenta
Rossini P.M. [7]; Pasqualetti P.
[2] *; Pozzilli C. [5]; Grasso M.G. [3]; Millefiorini E. [5]; Graceffa
A. [3]; Carlesimo G.A. [3]; Zibellini G. [6]; Caltagirone C. [4]
[2] IRCSS 'San Giovanni di Dio'
Fatebenefratelli, Brescia, Italy [3] IRCSS 'S. Lucia', Rome, Italy [4]
Clinica Neurologica, Università 'Tor Vergata', Rome, Italy [5] Dip.
Scienze Neurologiche, Università 'La Sapienza', Rome, Italy [6]
Dept. Research, Sigma-Tau Industries, Pomezia, Italy [7] Neurology, Università
Campus Biomedico, Rome, Italy [*] Correspondence: P Pasqualetti, Direzione
Scientifica, Ospedale Fatebenefratelli-Isola Tiberina, 00186 Roma, Italy
Abstract: