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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox | all eligible subjects, in a reverse consecutive order, initiated on onaBoNT-A from 01 March 2015 to 29 May 2017. | ||
| Dysport | all subjects meeting inclusion/exclusion criteria and initiated on aboBoNT-A from 30 May 2017 to 30 March 2019. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Goal Attainment Scale (GAS T) score 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". | 6 weeks |
| Average Goal Attainment Scale (GAS T) score 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". | 12 weeks |
| Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal | 12 weeks | |
| Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal | 6 weeks | |
| Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal | 12 weeks | |
| Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average total dose | Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection) | |
| Average dose per limb and per type of muscle injected | Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection) |
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Inclusion Criteria :
Exclusion Criteria :
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All adult subjects with Upper Limb Spasticity and/or Lower Limb Spasticity complying with all inclusion and exclusion criteria during the study enrolment period will be included in this study. This study is retrospective and non-interventional, and as such, subjects will have been treated in accordance with usual medical practice during the study period. No additional assessments or tests will be required.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust. | Stafford | ST6 7AG | United Kingdom |
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| Distribution of vials used | If Dysport® 300U / 500U, if Botox® 50U / 100U / 200U | Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection) |
| Distribution of localisation methods | Ultrasound, electrostimulation, palpation, electromyography | Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection) |
| Distribution of limb and type of muscles injected | Upper limb: shoulder girdle, shoulder, arm, forearm, hand; lower limb: hip, thigh, leg and foot | 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) |
| Quality of Life (QoL) | The EQ-5D-VAS is used to evaluate patients' quality of life. EQ-5D-VAS is one component of the EQ-5D-5L, a generic, preference-based measure of health-related quality of life. The questions are answered based on how the subject is feeling "today". | From baseline up to 12 weeks |
| 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 | A Likert scale is used to record patient's satisfaction with his/her progress, and the patient's "best response" (since index date) and "response now" (at the time of the review) on a five-category scale: From "Much worse" to "Much better" | From baseline up to 12 weeks |