A Single Centre, Non-interventional, Retrospective Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spasticity Related to Any Cause Except Cerebral Palsy
- Sponsor
- Ipsen
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Average Goal Attainment Scale (GAS T) score 12 weeks
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The aim of the study is to describe treatment outcomes of abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) treatments, after one injection of either treatment, in toxin-naïve adult patients with upper and/or lower limb spasticity at a single National Health Service (NHS) centre in the United Kingdom (UK).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Average Goal Attainment Scale (GAS T) score 12 weeks
Time Frame: 12 weeks
GAS, a method that evaluates the attainment of priority goals that are of importance to the patient and has been previously used for the management of patients with limb spasticity. Rating is performed for each domain from -3 "worse than at start" to +2 "much more than expected: clear improvement".
Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
Time Frame: 12 weeks
Average Goal Attainment Scale (GAS T) score 6 weeks
Time Frame: 6 weeks
GAS, a method that evaluates the attainment of priority goals that are of importance to the patient and has been previously used for the management of patients with limb spasticity. Rating is performed for each domain from -3 "worse than at start" to +2 "much more than expected: clear improvement".
Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
Time Frame: 6 weeks
Secondary Outcomes
- Average total dose(Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection))
- Distribution of vials used(Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection))
- Distribution of localisation methods(Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection))
- Distribution of limb and type of muscles injected(Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection))
- Proportion of patients who require re-injection between aboBoNT-A and onaBoNT-A(Week 6 and week 12 (re-injection))
- Average dose per limb and per type of muscle injected(Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection))
- Average number of unscheduled visits(From baseline up to end of the study (up to 24 weeks))
- Proportion of patients with ≥1 unscheduled visit(From baseline up to end of the study (up to 24 weeks))
- Proportion of patients with at least "the same", or at least "better" satisfaction with their treatment as measured using a Likert scale(From baseline up to 12 weeks)
- Quality of Life (QoL)(From baseline up to 12 weeks)