SPACE: International, non-interventional study of botulinum toxin in treatment of spasticity

Abstract

Intramuscular injections with botulinum neurotoxin type A (BoNT-A) have become the first-line treatment for most patients with focal and multifocal spasticity. Multiple controlled trials have demonstrated the safety and efficacy of repeated BoNT-A injections for patients with focal spasticity. However, there is a lack of data on treatment approaches in real-life clinical practice and data on which patients in this diverse population are most likely to benefit from BoNT-A treatment. The purpose of the SPAsticity in PractiCE (SPACE) study is to understand how physicians use BoNT in the long-term management of spasticity, to evaluate the safety and efficacy of treatment with BoNT-A in “real-life” clinical practice and to collect information on treating physicians and their treatment preferences and decisions. SPACE is a prospective, non-interventional, open-label, multicenter, multinational study (106 active sites in 9 countries). Participants can receive any number of treatment sessions with any BoNT-A product available in their country, at the discretion of their physician according to individual patients’ needs and physician's routine clinical practice. Internationally 756 patients aged ≥ 18 years were included with spasticity of any aetiology who require BoNT-A injections and who have not been previously treated with BoNT-A or BoNT-B for any indication. In total, 106 active sites and 230 physicians were involved. In France, 126 patients were included, 21 active sites and 24 physicians were involved. Results show that most patients (66.4% overall) had post-stroke spasticity and that the most important key treatment goals were improvements of functionality (especially “in mobility” and “in dexterity and reaching”). SPACE will help to further define the role of BoNT-A as part of a multimodal management approach for focal spasticity and to improve patient treatment according their needs. Data collected will help to identify challenges physicians face in managing patients with focal spasticity.