Journal article

Publication year: 2011

Pages: 15-22

Journal: Journal of Rehabilitation Medicine

Volume number: 43

Issue number: 1

ISSN: 1650-1977

Open access status: Gold

DOI Link: https://doi.org/10.2340/16501977-0663

Publisher: Medical Journals Sweden

Abstract: 

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.

Harvard Citation style: Borg, J., Ward, A., Wissel, J., Kulkarni, J., Sakel, M., Ertzgaard, P., et al. (2011) 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, Journal of Rehabilitation Medicine, 43(1), pp. 15-22. https://doi.org/10.2340/16501977-0663

APA Citation style: Borg, J., Ward, A., Wissel, J., Kulkarni, J., Sakel, M., Ertzgaard, P., Akerlund, P., Reuter, I., Herrmann, C., Satkunam, L., Wein, T., Girod, I., & Wright, N. (2011). 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. Journal of Rehabilitation Medicine. 43(1), 15-22. https://doi.org/10.2340/16501977-0663