Clinical trial NCT04396704: A Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasticity Related to Any Cause Except Cerebral Palsy
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2020-05-20
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Average Goal Attainment Scale (GAS T) score 6 weeks
timeFrame: 6 weeks
measure: Average Goal Attainment Scale (GAS T) score 12 weeks
timeFrame: 12 weeks
measure: Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
timeFrame: 12 weeks
measure: Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
timeFrame: 6 weeks
measure: Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
timeFrame: 12 weeks
measure: Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
timeFrame: 6 weeks
Secondary outcomes:
measure: Average total dose
timeFrame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
measure: Average dose per limb and per type of muscle injected
timeFrame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
measure: Distribution of vials used
timeFrame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
measure: Distribution of localisation methods
timeFrame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
measure: Distribution of limb and type of muscles injected
timeFrame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
measure: Proportion of patients who require re-injection between aboBoNT-A and onaBoNT-A
timeFrame: Week 6 and week 12 (re-injection)
measure: Quality of Life (QoL)
timeFrame: From baseline up to 12 weeks
measure: Average number of unscheduled visits
timeFrame: From baseline up to end of the study (up to 24 weeks)
measure: Proportion of patients with ≥1 unscheduled visit
timeFrame: From baseline up to end of the study (up to 24 weeks)
measure: Proportion of patients with at least "the same", or at least "better" satisfaction with their treatment as measured using a Likert scale
timeFrame: From baseline up to 12 weeks
Other outcomes:
Locations:
city: Stafford
country: United Kingdom
facility: North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust.
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: