Spasticity Related to Any Cause Except Cerebral Palsy Clinical Trial
Official title:
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.
| Verified date | May 2021 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 114 |
| Est. completion date | March 30, 2021 |
| Est. primary completion date | March 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria : - Patient diagnosed with spasticity related to any cause except cerebral palsy. - Patient initiated on treatment with either onaBoNT-A or aboBoNT-A during the study enrolment periods. - Patient is an adult aged =18 years old at the time of the first BoNT-A injection for spasticity - Patient has not received treatment with any type of BoNT-A 6 months prior to initiation of onaBoNT-A or aboBoNT-A. For patients with multiple courses of BoNT-A, separated by a gap of 6 months, only the first course will be evaluated in this study. - Patient is being treated at Haywood Hospital at index date and during follow-up for up to 24 weeks post-index date, with medical records available for review. Exclusion Criteria : - Patient is participating in an interventional clinical trial of an investigational medicinal product for the treatment of spasticity at index date and/or during follow-up. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust. | Stafford |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | Proportion of patients who achieve GAS-T score =0 for impairment/ symptoms goal | 12 weeks | ||
| Primary | Proportion of patients who exceed GAS-T score =1 for impairment/ symptoms goal | 6 weeks | ||
| Primary | Proportion of patients who exceed GAS-T score =1 for impairment/ symptoms goal | 12 weeks | ||
| Primary | Proportion of patients who achieve GAS-T score =0 for impairment/ symptoms goal | 6 weeks | ||
| Secondary | Average total dose | Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection) | ||
| Secondary | Average dose per limb and per type of muscle injected | Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection) | ||
| Secondary | 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) | |
| Secondary | Distribution of localisation methods | Ultrasound, electrostimulation, palpation, electromyography | Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection) | |
| Secondary | 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) | |
| Secondary | Proportion of patients who require re-injection between aboBoNT-A and onaBoNT-A | Week 6 and week 12 (re-injection) | ||
| Secondary | 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 | |
| Secondary | Average number of unscheduled visits | From baseline up to end of the study (up to 24 weeks) | ||
| Secondary | Proportion of patients with =1 unscheduled visit | From baseline up to end of the study (up to 24 weeks) | ||
| Secondary | 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 |