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

BackgroundIntramuscular 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.MethodsSPACE is a prospective, non-interventional, open-label, multicenter, multinational study (106active sites in 9countries). 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.ResultsInternationally 756patients aged≥18years 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, 106active sites and 230physicians were involved. In France, 126patients were included, 21active sites and 24physicians 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”).ConclusionSPACE 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