Spasticity Related to Any Cause Except Cerebral PalsyNCT04396704
A Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.
An observational study of Spasticity Related to Any Cause Except Cerebral Palsy, run by Ipsen at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity Related to Any Cause Except Cerebral Palsy
- How many people
- 114 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jan 2021to 30 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust.
Stafford, ST6 7AG
About this study
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.
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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 12 weeks
Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
Measured: 12 weeks
Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
Measured: 6 weeks
Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
Measured: 12 weeks
Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
Measured: 6 weeks
Secondary outcomes (10)
Average total dose
Measured: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
Average dose per limb and per type of muscle injected
Measured: 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
Measured: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)
Distribution of localisation methods
Ultrasound, electrostimulation, palpation, electromyography
Measured: 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
Measured: 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
Measured: 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".
Measured: From baseline up to 12 weeks
Average number of unscheduled visits
Measured: From baseline up to end of the study (up to 24 weeks)
Proportion of patients with ≥1 unscheduled visit
Measured: 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"
Measured: From baseline up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start11 Jan 2021
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity Related to Any Cause Except Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396704
- Sponsor's protocol ID
- F-GB-52120-268
- Status last verified
- May 2021
- First submitted
- 5 May 2020
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04396704
- Acronym / sponsor ID
- F-GB-52120-268
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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".
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".
Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
Time frame: 12 weeks
Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
Time frame: 6 weeks
Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
Time frame: 12 weeks
Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
Time frame: 6 weeks
10 secondary outcomes
Average total dose
Time frame: 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)
Distribution of vials used
Time frame: 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)
Distribution of limb and type of muscles injected
Time frame: 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)
Quality of Life (QoL)
Time frame: 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)
Proportion of patients with ≥1 unscheduled visit
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity Related to Any Cause Except Cerebral Palsy, run by Ipsen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Goal Attainment Scale (GAS T) score 6 weeks (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.