Adult Spasticity International Registry Study: methodology and baseline patient, healthcare provider, and caregiver characteristics.

[OBJECTIVE] The main aim of this study was to determine the utilization patterns and effectiveness of onabotulinumtoxinA (Botox®) for treatment of spasticity in clinical practice.

[DESIGN] An international, multicentre, prospective, observational study at selected sites in North America, Europe, and Asia.

[PATIENTS] Adult patients with newly diagnosed or established focal spasticity, including those who had previously received treatment with onabotulinum-toxin A.

[METHODS] Patients were treated with onabotulinumtoxinA, approximately every 12 weeks, according to their physician's usual clinical practice over a period of up to 96 weeks, with a final follow-up interview at 108 weeks. Patient, physician and caregiver data were collected.

[RESULTS] Baseline characteristics are reported. Of the 745 patients enrolled by 75 healthcare providers from 54 sites, 474 patients had previously received onabotulinumtoxinA treatment for spasticity. Lower limb spasticity was more common than upper limb spasticity, with stroke the most common underlying aetiology. The Short-Form 12 (SF-12) health survey scores showed that patients' spasticity had a greater perceived impact on physical rather than mental aspects.

[CONCLUSION] The data collected in this study will guide the development of administration strategies to optimize the effectiveness of onabotulinumtoxinA in the management of spasticity of various underlying aetiologies.