RATIONALE AND DESIGN OF A MULTICENTRE, DOUBLE-BLIND, PROSPECTIVE, RANDOMIZED, EUROPEAN AND CANADIAN STUDY: EVALUATING PATIENT OUTCOMES AND COSTS OF MANAGING ADULTS WITH POST-STROKE FOCAL SPASTICITY
2011 (English)In: JOURNAL OF REHABILITATION MEDICINE, ISSN 1650-1977, Vol. 43, no 1, 15-22 p.Article in journal (Refereed) Published
Objective: This report describes the design of a study aiming to provide evidence for the extended use of botulinum toxin A (BOTOX(R), Allergan Inc.) in focal post-stroke upper and lower limb spasticity and to evaluate the impact of incorporating botulinum toxin A treatment into the rehabilitation of patients with spasticity. Design: International, prospective, randomized, double-blind, placebo-controlled study with an open-label extension. Methods: Approximately 300 adults with a stroke occurring 23 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 A+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: The BOTOX(R) 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.
Place, publisher, year, edition, pages
Foundation for Rehabilitation Information , 2011. Vol. 43, no 1, 15-22 p.
botulinum toxin A, cost-effectiveness, goal attainment scaling, post-stroke spasticity, stroke rehabilitation
Medical and Health Sciences
IdentifiersURN: urn:nbn:se:liu:diva-66871DOI: 10.2340/16501977-0663ISI: 000288105200003OAI: oai:DiVA.org:liu-66871DiVA: diva2:405306