Article

Randomized, double-blind, placebo-controlled, two-period
crossover.Objectives:To evaluate the efficacy and safety of arbaclofen placarbil
(AP) in patients with spasticity secondary to spinal cord injury
(SCI).Setting:United States and Canada.Methods:Patients received extended-release
AP tablets 10, 20 or 30 mg every 12 h in one of two AP/placebo sequences, with 26
days of each treatment. The primary analysis compared Ashworth scale assessments
of muscle tone between AP and placebo for the muscle group with maximum baseline
Ashworth score. Secondary endpoints included a patient-rated Severity of
Spasticity Scale.Results:In the primary analysis, AP significantly improved
Ashworth scores compared with placebo over the dosing interval: least-squares
mean reduction versus placebo was 0.60 for AP 20 mg (P=0.0059) and 0.88 for AP 30
mg (P=0.0007). The difference was significant for the pre-morning dose time
point, 12 h after the prior evening dose, indicating that efficacy was maintained
throughout the dosing interval. Treatment differences for AP 10 mg versus placebo
were not significant. Severity of Spasticity ratings were significantly reduced
for the combined 20/30-mg group versus placebo (P=0.018). No statistically
significant differences between AP and placebo were observed for muscle strength.
AP-related AEs were generally mild to moderate in intensity, and none led to
early withdrawal or were serious.Conclusion:AP was well tolerated at all
investigated dosages and, when administered at doses of 20 or 30 mg twice daily,
was efficacious in reducing spasticity due to SCI.

Langue : ANGLAIS