A Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.
- Conditions
- Spasticity Related to Any Cause Except Cerebral Palsy
- Registration Number
- NCT04396704
- Lead Sponsor
- Ipsen
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average Goal Attainment Scale (GAS T) score 12 weeks 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 12 weeks Average Goal Attainment Scale (GAS T) score 6 weeks 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 6 weeks
- Secondary Outcome Measures
Name Time Method 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) If Dysport® 300U / 500U, if Botox® 50U / 100U / 200U
Distribution of localisation methods Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection) Ultrasound, electrostimulation, palpation, electromyography
Distribution of limb and type of muscles injected Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection) Upper limb: shoulder girdle, shoulder, arm, forearm, hand; lower limb: hip, thigh, leg and foot
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 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"
Quality of Life (QoL) From baseline up to 12 weeks 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".
Trial Locations
- Locations (1)
North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust.
🇬🇧Stafford, United Kingdom