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

May 20, 2021 updated by: Ipsen

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average Goal Attainment Scale (GAS T) score 6 weeks
Time Frame: 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
Time Frame: 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
Time Frame: 12 weeks
12 weeks
Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
Time Frame: 6 weeks
6 weeks
Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
Time Frame: 12 weeks
12 weeks
Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average total dose
Time Frame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
Average dose per limb and per type of muscle injected
Time Frame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
Distribution of vials used
Time Frame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
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
Time Frame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
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
Time Frame: 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
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
Time Frame: Week 6 and week 12 (re-injection)
Week 6 and week 12 (re-injection)
Quality of Life (QoL)
Time Frame: 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".
From baseline up to 12 weeks
Average number of unscheduled visits
Time Frame: From baseline up to end of the study (up to 24 weeks)
From baseline up to end of the study (up to 24 weeks)
Proportion of patients with ≥1 unscheduled visit
Time Frame: From baseline up to end of the study (up to 24 weeks)
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
Time Frame: 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"
From baseline up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F-GB-52120-268

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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