A Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.

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.

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).

Study Overview

• Status: Completed
• Conditions: Spasticity Related to Any Cause Except Cerebral Palsy

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• United Kingdom
  • Stafford, United Kingdom, ST6 7AG
    • North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)
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

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: F-GB-52120-268