ASPIRE
Research type
Research Study
Full title
ASPIRE: Adult SPasticity International REgistry on BOTOX® Treatment
IRAS ID
144082
Contact name
Ganesh Bavikatte
Contact email
Sponsor organisation
Allergan, Inc.
Research summary
This is an international, multi-centre, prospective observational study conducted at selected sites in North America, Europe and Asia. The study will determine patterns of utilisation of BOTOX for the treatment of spasticity, including, but not limited to, characteristics of enrolling and treating healthcare professionals (HCPs) and practices, characteristics of patients and details of administration. This study will also assess the product effectiveness, as measured by satisfaction and safety. Additionally, and if applicable, patterns of utilisation of BOTOX for the treatment of additional therapeutic and cosmetic indications in a subset of patients treated with BOTOX for spasticity will be described and verified by the treating HCP.
The study aims to enrol 1000 patients treated with BOTOX for spasticity and collect treatment administration information at the initial and every follow-up treatment episode visit (approximately every 12 weeks). To address the primary endpoint of treatment satisfaction and the secondary endpoint of interest (pain and quality of life), patients will be asked to complete assessments at baseline and then 5 weeks (± 1 week) after each BOTOX treatment episode. For those patients who are treatment naïve and who have caregivers enrolled, the caregiver will be asked to complete an assessment of caregiver burden at baseline and then again after the second BOTOX spasticity treatment episode. Patients will be observed for up to 108 weeks after initial treatment in the study.
The study will not provide or recommend any treatment; all decisions regarding treatment are made at the sole discretion of the treating HCP in accordance with their usual practices.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
13/EM/0479
Date of REC Opinion
9 Jan 2014
REC opinion
Favourable Opinion