CARegiver BURden, Effectiveness and Other Health Care Measures on Functional Disability, in Patients Treated With Abobotulinumtoxin A for Upper Limb Spasticity
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.
1 other identifier
observational
113
1 country
27
Brief 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 injuries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2023
Typical duration for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 16, 2023
CompletedFirst Submitted
Initial submission to the registry
January 22, 2024
CompletedFirst Posted
Study publicly available on registry
February 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
May 4, 2026
April 1, 2026
2.5 years
January 22, 2024
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
From baseline to 8 weeks
Secondary Outcomes (29)
Patient's demographic data
through study completion, an average of 14 months
Caregiver's demographic data;
through study completion, an average of 14 months
Aetiology of spasticity;
through study completion, an average of 14 months
Affected upper limb
through study completion, an average of 14 months
Ascribed spastic muscle group(s);
through study completion, an average of 14 months
- +24 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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;
- 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 :
- (8) 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.
You may not qualify if:
- 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;
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (27)
CH Bagnères
Bagnères-de-Bigorre, 65201, France
CH Bar le Duc
Bar-le-Duc, 55012, France
Besançon - CHU/CRRF de Bréguille/Salin les bains
Besançon, 25030, France
CHU Bordeaux - Hopital Tastet-Girard
Bordeaux, 33076, France
CH Bourg en Bresse
Bourg-en-Bresse, 01012, France
CHU Brest
Brest, 29609, France
Centre de rééducation des 3 vallées
Corbie, France
CH Dax
Dax, 40107, France
Fondation hopale - Fouqière-lez-Lens
Fouquières-lès-Lens, 62HEN, France
Clinique de Verdaich
Gaillac-Toulza, France
HCL - Renée Sabran
Hyères, 83406, France
Crf Bel Air
La Membrolle-sur-Choisille, France
CHU Lille
Lille, 59000, France
CHU Nice
Nice, 06202, France
CHU Nîmes
Nîmes, 30029, France
Hôpital Rothschild
Paris, 75012, France
Ste Anne
Paris, 75674, France
Hôpital Fondation Adolphe de Rothschild
Paris, France
CHU Reims
Reims, 51092, France
CHU Rennes
Rennes, 35033, France
Pole St Hélier
Rennes, 35043, France
Fondation Ildys - Roscoff
Roscoff, 29684, France
SSR Val Rosay UGECAM
Saint-Didier-au-Mont-d'Or, 69370, France
CH Ariège Couserans Site de Rozès
Saint-Girons, France
CH Saint Jean de Luz
Saint-Jean-de-Luz, 64502, France
CHU Toulouse
Toulouse, 31059, France
CH Troyes
Troyes, 10000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2024
First Posted
February 7, 2024
Study Start
November 16, 2023
Primary Completion (Estimated)
May 29, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
- Access Criteria
- Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
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.