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Assessing the impact of Abobotulinumtoxin A on caregiver burden and functional disability in patients with upper limb spasticity

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.

Observational Ipsen · NCT06245772

This study is testing whether a treatment called Abobotulinumtoxin A can help reduce the challenges faced by caregivers and improve daily function for people with upper limb spasticity after brain injuries.

Quick facts

Study typeObservational
Enrollment113 (estimated)
Ages18 Years and up
SexAll
SponsorIpsen Industry-sponsored
Locations37 sites (Bagnères-de-Bigorre and 36 other locations)
Trial IDNCT06245772 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effects of Abobotulinumtoxin A on patients with upper limb spasticity resulting from acquired brain injuries. It will gather insights from patients, caregivers, and physicians to understand the treatment's impact on caregiver burden and functional disability. The study will take place in real-world clinical settings, focusing on the experiences of those involved in the care process. Participants will be monitored for their health care measures and overall well-being.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with upper limb spasticity due to non-progressive acquired brain injuries and who have a designated caregiver.

Not a fit: Patients with progressive conditions or those without a supportive caregiver may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into improving the quality of life for patients and their caregivers dealing with upper limb spasticity.

How similar studies have performed: While this approach is observational and builds on existing knowledge, similar studies have shown promise in understanding caregiver dynamics and treatment impacts.

Eligibility criteria

Show full inclusion / exclusion criteria 
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) or due to non-progressive spinal cord injury with stability of spasticity of the upper limbs;
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.

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.

Exclusion Criteria:

1. Contraindication to BoNT-A treatment;
2. Previously treated with BoNT-A in upper limbs within the last 12 months;
3. Patients and if applicable Legally Authorized Representative (LAR) of patient under curatorship or deprived of liberty 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 those who have been hospitalized for the purpose of their BoNT-A injection (maximum length of stay as per clinical judgment of the investigator);
8. Vulnerable patients (i.e. pregnant and/or lactating women, children, patient under curatorship or deprived of liberty).

Where this trial is running

Bagnères-de-Bigorre and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Upper Limb Injury
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.