Article

Two randomized, double-blind, placebo-controlled trials. Objective:To
evaluate the efficacy and safety of fampridine sustained-release tablets
(fampridine-SR) 25 mg twice daily for moderate-to-severe spasticity in patients
with chronic spinal cord injury (SCI).Setting:United States and
Canada.Methods:Patients with incomplete chronic SCI were randomized to twice
daily fampridine-SR 25 mg or placebo, with a 2-week single-blind placebo run-in,
a 2-week titration, 12 weeks of stable dosing, 2 weeks of downward titration and
2 weeks of untreated follow-up. Co-primary end points were the change from
baseline, averaged over the double-blind treatment period, for Ashworth score
(bilateral knee flexors and extensors) and a 7-point Subject Global Impression of
treatment (SGI; 1, terrible; 7, delighted). Secondary end points were: Penn Spasm
Frequency Scale; the motor/sensory score from the International Standards for
Neurological Classification of SCI; Clinician's Global Impression of Change of
neurological status; and the International Index of Erectile Function (men) or
the Female Sexual Function Index (women).Results:The populations were 212 and 203
patients in the two studies, respectively. Changes from baseline in Ashworth
score were -0.15 (placebo) and -0.19 (fampridine-SR) in the first study, and
-0.16 (placebo) and -0.28 (fampridine-SR) in the second study. The
between-treatment difference was not significant for either the Ashworth score or
the SGI and, with few exceptions, neither were the secondary end points.
Fampridine-SR was generally well tolerated; treatment-emergent adverse events
(TEAEs) and serious TEAEs were reported with similar frequency between
treatments.Conclusion:Fampridine-SR was well tolerated. No significant
differences were observed between treatment groups for the primary end points of
Ashworth score and SGI.

Langue : ANGLAIS