Upper Limb InjuryCARBURNCT06245772
CARegiver BURden, Effectiveness and Other Health Care Measures on Functional Disability, in Patients Treated With Abobotulinumtoxin A for Upper Limb Spasticity
An observational study of Upper Limb Injury, run by Ipsen at 27 sites in France.
Trial summary
The aim of this study is to perform, in real world clinical practice, a three-dimensional assessment from patient's, caregiver's and physician's perspectives, of the impact of AboBoNT-A on caregiver burden, functional disability and other health care measures in patients affected with ULS due to acquired brain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Injury
- How many people
- 113 participants
- Where
- 27 sitesFrance
- Study dates
- 16 Nov 2023to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients with ULS who will start AboBoNT-A treatment in upper limbs as part of routine clinical practice should be recruited. Patients who received BoNT-A injections in upper limbs less than one year prior to inclusion should not be included in the study. Patients who previously received BoNTA injections in body parts other than upper limbs could be included in the study, regardless of injection anteriority.
Who may be able to join
- The patient is able to comply with the protocol;
- Male and female patients who are at least 18 years old;
- The patient is supported by an identified caregiver (family member or other nonpaid adult
- if the patient has more than one caregiver, the main caregiver will be selected) who provides daily supervision or direct assistance to the care recipient;
- The patient has been diagnosed with ULS due to non-progressive acquired brain injuries (stroke, traumatic brain injury, surgical resection of non-progressive tumours, other) or due to non-progressive spinal cord injury with stability of spasticity of the upper limbs;
- The decision to treat the patient with AboBoNT-A by the care provider will be made prior to, and independently from the decision to enrol the patient in the observational study;
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- The patient is covered by a healthcare insurance;
- The cognitive and health status of the patient is compatible with the participation to the study.
- For Caregivers :
- The caregiver is able to comply with the protocol; (9) Male and female caregivers who are at least 18 years old; (10) The cognitive and health status of the caregiver is compatible with the participation to the study.
Who cannot join
- Contraindication to BoNT-A treatment;
- Previously treated with BoNT-A in upper limbs within the last 12 months;
- Patients and if applicable Legally Authorized Representative (LAR) of patient under curatorship or deprived of liberty who are opposed to their data collection
- Caregivers who are opposed to their data collection;
- Caregivers already included for another patient;
- Current participation in any other interventional clinical study or have participated within the 12 weeks prior to the inclusion visit;
- Non-ambulatory patients except for those who have been hospitalized for the purpose of their BoNT-A injection (maximum length of stay as per clinical judgment of the investigator);
- Vulnerable patients (i.e. pregnant and/or lactating women, children, patient under curatorship or deprived of liberty).
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
CH Bagnères
Bagnères-de-Bigorre, 65201
CH Bar le Duc
Bar-le-Duc, 55012
Besançon - CHU/CRRF de Bréguille/Salin les bains
Besançon, 25030
CHU Bordeaux - Hopital Tastet-Girard
Bordeaux, 33076
CH Bourg en Bresse
Bourg-en-Bresse, 01012
CHU Brest
Brest, 29609
Centre de rééducation des 3 vallées
Corbie
CH Dax
Dax, 40107
Fondation hopale - Fouqière-lez-Lens
Fouquières-lès-Lens, 62HEN
Clinique de Verdaich
Gaillac-Toulza
HCL - Renée Sabran
Hyères, 83406
Crf Bel Air
La Membrolle-sur-Choisille
CHU Lille
Lille, 59000
CHU Nice
Nice, 06202
CHU Nîmes
Nîmes, 30029
Hôpital Rothschild
Paris, 75012
Ste Anne
Paris, 75674
Hôpital Fondation Adolphe de Rothschild
Paris
CHU Reims
Reims, 51092
CHU Rennes
Rennes, 35033
Pole St Hélier
Rennes, 35043
Fondation Ildys - Roscoff
Roscoff, 29684
SSR Val Rosay UGECAM
Saint-Didier-au-Mont-d'Or, 69370
CH Ariège Couserans Site de Rozès
Saint-Girons
CH Saint Jean de Luz
Saint-Jean-de-Luz, 64502
CHU Toulouse
Toulouse, 31059
CH Troyes
Troyes, 10000
About this study
Official title: CARBUR: A National, Multicentre, Non-interventional, Prospective, Longitudinal Study to Assess CARegiver BURden, Effectiveness and Other Health Care Measures on Functional Disability, in Patients Treated With Abobotulinumtoxin A for Upper Limb Spasticity in Routine Clinical Practice.
The aim of this study is to perform, in real world clinical practice, a three-dimensional assessment from patient's, caregiver's and physician's perspectives, of the impact of AboBoNT-A on caregiver burden, functional disability and other health care measures in patients affected with ULS due to acquired brain injuries.
- Conditions
- Upper Limb Injury
- Medical subject headings
- Arm Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the 5-item Carer Burden Scale (CBS) mean score
The 5-item Carer Burden Scale is 5-point Likert scale ranging from 0 (no difficulty) to 4 (cannot complete the task), so that higher scores indicate greater burden.
Measured: From baseline to 8 weeks
Secondary outcomes (29)
Patient's demographic data
Patient's Characteristics
Measured: through study completion, an average of 14 months
Caregiver's demographic data;
Patient's Characteristics
Measured: through study completion, an average of 14 months
Aetiology of spasticity;
Patient's Characteristics
Measured: through study completion, an average of 14 months
Affected upper limb
Patient's Characteristics
Measured: through study completion, an average of 14 months
Ascribed spastic muscle group(s);
Patient's Characteristics
Measured: through study completion, an average of 14 months
Time since onset of the aetiology of upper limb spasticity (ULS)
Patient's Characteristics
Measured: through study completion, an average of 14 months
Associated lower limb spasticity (LLS)
Patient's Characteristics
Measured: through study completion, an average of 14 months
Global autonomy evaluation (modified Rankin Scale).
Patient's Characteristics
Measured: through study completion, an average of 14 months
Total dose injected in ULS per cycle;
Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.
Measured: through study completion, an average of 14 months
Dose per muscle group;
Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.
Measured: through study completion, an average of 14 months
Number of injected muscle group(s)
Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.
Measured: through study completion, an average of 14 months
Injections Practices - Total dose injected per cycle (any indication);
Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.
Measured: through study completion, an average of 14 months
Time between two injections;
Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.
Measured: through study completion, an average of 14 months
Criteria for reinjection;
Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.
Measured: through study completion, an average of 14 months
Reasons for treatment discontinuation, if any, and subsequent therapy if any.
Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.
Measured: through study completion, an average of 14 months
Change from baseline in Carer Burden Scale (CBS)
Caregiver Burden; The impact of treatment on the physical burden of the caregiver will be assessed by the same caregiver using a modified paper version of the CBS self-administered questionnaire
Measured: through study completion, an average of 14 months
Change from baseline in ZBI-12 total score to the end of each AboBoNT-A cycle
Treatment Effectiveness; ZBI-12 is a self-administered questionnaire for measuring caregiving burden
Measured: through study completion, an average of 14 months
Goal score
Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals
Measured: through study completion, an average of 14 months
Goal score change
Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals
Measured: through study completion, an average of 14 months
Distribution of Goals each AboBoNT-A cycle;
Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals
Measured: through study completion, an average of 26 months
Proportion of patients "attaining" the primary Goal
Treatment Effectiveness
Measured: through study completion, an average of 14 months
Proportion of patients "attaining" at least one Goal
Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals
Measured: through study completion, an average of 14 months
Proportion of patients "attaining" the pre-defined goal
Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals
Measured: through study completion, an average of 14 months
Change from baseline in Modified Ashworth Scale (MAS) score.
Treatment Effectiveness; Based on routine clinical examination, group muscle tone assessments performed by the Investigator according to the MAS will be recorded
Measured: through study completion, an average of 14 months
Change from baseline in SQoL-6D total score
Patient's Spasticity-Related Health Status (PS-RHS); The SQoL-6D consists of a 6-dimensions self-administered questionnaire that provides an overall picture of ULS spasticity-related health status
Measured: through study completion, an average of 14 months
Change from baseline in SQoL-6D pain/discomfort subscore
Patient's Spasticity-Related Health Status (PS-RHS); The SQoL-6D consists of a 6-dimensions self-administered questionnaire that provides an overall picture of ULS spasticity-related health status
Measured: through study completion, an average of 14 months
Number and percentage of patients with the following concomitant medications: oral antispasticity medications, pain medications (nociceptive and neuropathic pain), psychotropic drugs and anticoagulant drugs.
Concomitant Medications, Non-Drug Therapies and Surgeries
Measured: Up to 14 months
Number and percentage of patients with the following concomitant non-drug therapies for the management of ULS: physiotherapy and use of orthoses;
Concomitant Medications, Non-Drug Therapies and Surgeries
Measured: Up to 14 months
Number and percentage of patients with concomitant surgical procedures impacting caregivers' burden and patients' health.
Concomitant Medications, Non-Drug Therapies and Surgeries
Measured: Up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start16 Nov 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb InjuryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 113 participants (estimated)
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
- NCT06245772
- Sponsor's protocol ID
- CLIN-52120-459
- Acronym
- CARBUR
- Status last verified
- Sep 2026
- First submitted
- 22 Jan 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARBUR: A National, Multicentre, Non-interventional, Prospective, Longitudinal Study to Assess CARegiver BURden, Effectiveness and Other Health Care Measures on Functional Disability, in Patients Treated With Abobotulinumtoxin A for Upper Limb Spasticity in Routine Clinical Practice.
- ClinicalTrials.gov ID
- NCT06245772
- Acronym / sponsor ID
- CARBUR / CLIN-52120-459
- Conditions
- Upper Limb Injury
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 7 Feb 2024 (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 this study is to perform, in real world clinical practice, a three-dimensional assessment from patient's, caregiver's and physician's perspectives, of the impact of AboBoNT-A on caregiver burden, functional disability and other health care measures in patients affected with ULS due to acquired brain injuries.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with ULS who will start AboBoNT-A treatment in upper limbs as part of routine clinical practice should be recruited. Patients who received BoNT-A injections in upper limbs less than one year prior to inclusion should not be included in the study. Patients who previously received BoNTA injections in body parts other than upper limbs could be included in the study, regardless of injection anteriority.
Key inclusion criteria (10 listed)
- The patient is able to comply with the protocol;
- Male and female patients who are at least 18 years old;
- The patient is supported by an identified caregiver (family member or other nonpaid adult
- The patient has been diagnosed with ULS due to non-progressive acquired brain injuries (stroke, traumatic brain injury, surgical resection of non-progressive tumours, other) or due to non-progressive spinal cord injury with stability of spasticity of the upper limbs;
- The decision to treat the patient with AboBoNT-A by the care provider will be made prior to, and independently from the decision to enrol the patient in the observational study;
Key exclusion criteria (8 listed)
- Contraindication to BoNT-A treatment;
- Previously treated with BoNT-A in upper limbs within the last 12 months;
- Patients and if applicable Legally Authorized Representative (LAR) of patient under curatorship or deprived of liberty who are opposed to their data collection
- Caregivers who are opposed to their data collection;
- Caregivers already included for another patient;
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
Change from baseline in the 5-item Carer Burden Scale (CBS) mean score
Time frame: From baseline to 8 weeks
The 5-item Carer Burden Scale is 5-point Likert scale ranging from 0 (no difficulty) to 4 (cannot complete the task), so that higher scores indicate greater burden.
29 secondary outcomes
Patient's demographic data
Time frame: through study completion, an average of 14 months
Caregiver's demographic data;
Time frame: through study completion, an average of 14 months
Aetiology of spasticity;
Time frame: through study completion, an average of 14 months
Affected upper limb
Time frame: through study completion, an average of 14 months
Ascribed spastic muscle group(s);
Time frame: through study completion, an average of 14 months
Time since onset of the aetiology of upper limb spasticity (ULS)
Time frame: through study completion, an average of 14 months
Associated lower limb spasticity (LLS)
Time frame: through study completion, an average of 14 months
Global autonomy evaluation (modified Rankin Scale).
Time frame: through study completion, an average of 14 months
Total dose injected in ULS per cycle;
Time frame: through study completion, an average of 14 months
Dose per muscle group;
Time frame: through study completion, an average of 14 months
Number of injected muscle group(s)
Time frame: through study completion, an average of 14 months
Injections Practices - Total dose injected per cycle (any indication);
Time frame: through study completion, an average of 14 months
Time between two injections;
Time frame: through study completion, an average of 14 months
Criteria for reinjection;
Time frame: through study completion, an average of 14 months
Reasons for treatment discontinuation, if any, and subsequent therapy if any.
Time frame: through study completion, an average of 14 months
Change from baseline in Carer Burden Scale (CBS)
Time frame: through study completion, an average of 14 months
Change from baseline in ZBI-12 total score to the end of each AboBoNT-A cycle
Time frame: through study completion, an average of 14 months
Goal score
Time frame: through study completion, an average of 14 months
Goal score change
Time frame: through study completion, an average of 14 months
Distribution of Goals each AboBoNT-A cycle;
Time frame: through study completion, an average of 26 months
Proportion of patients "attaining" the primary Goal
Time frame: through study completion, an average of 14 months
Proportion of patients "attaining" at least one Goal
Time frame: through study completion, an average of 14 months
Proportion of patients "attaining" the pre-defined goal
Time frame: through study completion, an average of 14 months
Change from baseline in Modified Ashworth Scale (MAS) score.
Time frame: through study completion, an average of 14 months
Change from baseline in SQoL-6D total score
Time frame: through study completion, an average of 14 months
Change from baseline in SQoL-6D pain/discomfort subscore
Time frame: through study completion, an average of 14 months
Number and percentage of patients with the following concomitant medications: oral antispasticity medications, pain medications (nociceptive and neuropathic pain), psychotropic drugs and anticoagulant drugs.
Time frame: Up to 14 months
Number and percentage of patients with the following concomitant non-drug therapies for the management of ULS: physiotherapy and use of orthoses;
Time frame: Up to 14 months
Number and percentage of patients with concomitant surgical procedures impacting caregivers' burden and patients' health.
Time frame: Up to 14 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
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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
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Limb Injury, run by Ipsen at 27 sites in France.
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 10 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in the 5-item Carer Burden Scale (CBS) mean score (time frame: From baseline to 8 weeks). 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 10 Sep 2026.