CARegiver BURden, Effectiveness and Other Health Care Measures on Functional Disability, in Patients Treated With Abobotulinumtoxin A for Upper Limb Spasticity

Upper Limb Injury Clinical Trial

— CARBUR  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245772
• Other study ID #: CLIN-52120-459
• Status: Recruiting
• Start date: November 16, 2023
• Est. completion date: January 16, 2026

Study information

• Verified date: January 2024
• Source: Ipsen
• Contact: Ipsen Clinical Study Enquiries
• Phone: See e mail
• Email: clinical.trials[@]ipsen.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 injuries.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 133
• Est. completion date: January 16, 2026
• Est. primary completion date: January 16, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The patient is able to comply with the protocol;

2. Male and female patients who are at least 18 years old;

3. 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;

4. 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);

5. 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;

6. The patient is covered by a healthcare insurance;

7. The cognitive and health status of the patient is compatible with the participation to the study.

Exclusion Criteria:

1. Contraindication to BoNT-A treatment;

2. Previously treated with BoNT-A in upper limbs within the last 12 months;

3. Patients who are opposed to their data collection;

4. Caregivers who are opposed to their data collection;

5. Caregivers already included for another patient;

6. Current participation in any other interventional clinical study or have participated within the 12 weeks prior to the inclusion visit;

7. Non-ambulatory patients except for patients hospitalized for injection (maximum 48 hours) and day hospitalizations;

8. Vulnerable patients (i.e. pregnant and/or lactating women, children, patient under curatorship or deprived of liberty).

Related Conditions & MeSH terms

• Arm Injuries
• Caregiver Burden
• Upper Limb Injury

Locations

Country	Name	City	State
France	CH Bagnères	Bagnères-de-Bigorre
France	CH Bar le Duc	Bar-le-Duc
France	Besançon - CHU/CRRF de Bréguille/Salin les bains	Besançon
France	CHU Bordeaux - Hopital Tastet-Girard	Bordeaux
France	CH Bourg en Bresse	Bourg-en-Bresse
France	CHU Brest	Brest
France	SSR Tour de Gassies	Bruges
France	CH Colmar	Colmar
France	CH Dax	Dax
France	CRF DIivio Dijon	Dijon
France	Fondation hopale - Fouqière-lez-Lens	Fouquières-lès-Lens
France	Garches	Garche
France	Groupe Hospitalier De Gonesse	Gonesse
France	HCL - Renée Sabran	Hyères
France	CHU Lille	Lille
France	Clinique Saint-Martin Sud	Marseille
France	CHU Montpellier	Montpellier
France	CHU Nice	Nice
France	CHU Nîmes	Nîmes
France	Hôpital Rothschild	Paris
France	Ste Anne	Paris
France	CHU Reims	Reims
France	CHU Rennes	Rennes
France	Pole St Hélier	Rennes
France	Fondation Ildys - Roscoff	Roscoff
France	SSR Val Rosay UGECAM	Saint Didier au Mont d'Or
France	CH Saint Denis	Saint-Denis
France	CH Saint Jean de Luz	Saint-Jean-de-Luz
France	CHU Amiens	Salouël
France	CHU Toulouse	Toulouse
France	CH Troyes	Troyes

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 26 months
Secondary	Patient's demographic data	Patient's Characteristics	through study completion, an average of 26 months
Secondary	Caregiver's demographic data;	Patient's Characteristics	through study completion, an average of 26 months
Secondary	Aetiology of spasticity;	Patient's Characteristics	through study completion, an average of 26 months
Secondary	Affected upper limb	Patient's Characteristics	through study completion, an average of 26 months
Secondary	Ascribed spastic muscle group(s);	Patient's Characteristics	through study completion, an average of 26 months
Secondary	Time since onset of the aetiology of upper limb spasticity (ULS)	Patient's Characteristics	through study completion, an average of 26 months
Secondary	Associated lower limb spasticity (LLS)	Patient's Characteristics	through study completion, an average of 26 months
Secondary	Global autonomy evaluation (modified Rankin Scale).	Patient's Characteristics	through study completion, an average of 26 months
Secondary	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.	through study completion, an average of 26 months
Secondary	Dose per muscle group;	Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.	through study completion, an average of 26 months
Secondary	Number of injected muscle group(s)	Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.	through study completion, an average of 26 months
Secondary	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.	through study completion, an average of 26 months
Secondary	Time between two injections;	Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.	through study completion, an average of 26 months
Secondary	Criteria for reinjection;	Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.	through study completion, an average of 26 months
Secondary	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.	through study completion, an average of 26 months
Secondary	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	through study completion, an average of 26 months
Secondary	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	through study completion, an average of 26 months
Secondary	Goal score	Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals	through study completion, an average of 26 months
Secondary	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	through study completion, an average of 26 months
Secondary	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	through study completion, an average of 26 months
Secondary	Proportion of patients "attaining" the primary Goal	Treatment Effectiveness	through study completion, an average of 26 months
Secondary	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	through study completion, an average of 26 months
Secondary	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	through study completion, an average of 26 months
Secondary	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	through study completion, an average of 26 months
Secondary	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	through study completion, an average of 26 months
Secondary	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	through study completion, an average of 26 months
Secondary	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	Up to 26 months
Secondary	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	Up to 26 months
Secondary	Number and percentage of patients with concomitant surgical procedures impacting caregivers' burden and patients' health.	Concomitant Medications, Non-Drug Therapies and Surgeries	Up to 26 months