Article

This report describes the design of a study aiming to provide evidence
for the extended use of botulinum toxin A in focal post-stroke upper and lower
limb spasticity and to evaluate the impact of incorporating botulinum toxin
treatment into the rehabilitation of patients with spasticity. DESIGN:
International, prospective, randomized, double-blind, placebo-controlled study
with an open-label extension. Approximately 300 adults with a stroke
occurring >/= 3 months before screening, presenting with symptoms and signs of an
upper motor neuron syndrome and focal spasticity-related functional impairment,
were randomized to botulinum toxin (BOTOX(R), Allergan Inc.) + standard care or
placebo + standard care. Study medication was administered at baseline and again
at Week 12 if required, with follow-up to 52 weeks. The primary endpoint was the
number of patients who achieved their investigator-rated principal active
functional goal (as measured by Goal Attainment Scaling), at 10 weeks after the
second injection (Weeks 22-34) or at the 24-week visit if no second injection was
administered. Secondary endpoints included changes from baseline in level of goal
achievement, health-related quality of life and resource utilization. CONCLUSION:
Botulinum toxin A Economic Spasticity Trial (BEST) will provide information
regarding clinical and cost-effectiveness of botulinum toxin + standard care vs
standard care alone in patients with upper and/or lower limb post-stroke
spasticity typically seen in clinical practice. TRIAL REGISTRATION:
ClinicalTrials.gov number NCT-00549783.

Langue : ANGLAIS