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New study tracks Real-World impact of arm spasticity treatment on caregivers

NCT ID NCT06245772

Knowledge-focused Sponsor: Ipsen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study follows 113 adults with arm stiffness from brain injuries who are receiving botulinum toxin injections in routine care. Researchers measure how the treatment affects the burden on caregivers, the patient's disability, and other health factors over time. The goal is to understand the real-world benefits from the perspectives of patients, caregivers, and doctors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 113 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Arm Injuries injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Upper limb injury

Contacts and locations

Locations

  • Besançon - CHU/CRRF de Bréguille/Salin les bains

    Besançon, 25030, France

  • CH Ariège Couserans Site de Rozès

    Saint-Girons, France

  • CH Bagnères

    Bagnères-de-Bigorre, 65201, France

  • CH Bar le Duc

    Bar-le-Duc, 55012, France

  • CH Bourg en Bresse

    Bourg-en-Bresse, 01012, France

  • CH Dax

    Dax, 40107, France

  • CH Saint Jean de Luz

    Saint-Jean-de-Luz, 64502, France

  • CH Troyes

    Troyes, 10000, France

  • CHU Bordeaux - Hopital Tastet-Girard

    Bordeaux, 33076, France

  • CHU Brest

    Brest, 29609, France

  • CHU Lille

    Lille, 59000, France

  • CHU Nice

    Nice, 06202, France

  • CHU Nîmes

    Nîmes, 30029, France

  • CHU Reims

    Reims, 51092, France

  • CHU Rennes

    Rennes, 35033, France

  • CHU Toulouse

    Toulouse, 31059, France

  • Centre de rééducation des 3 vallées

    Corbie, France

  • Clinique de Verdaich

    Gaillac-Toulza, France

  • Crf Bel Air

    La Membrolle-sur-Choisille, France

  • Fondation Ildys - Roscoff

    Roscoff, 29684, France

  • Fondation hopale - Fouqière-lez-Lens

    Fouquières-lès-Lens, 62HEN, France

  • HCL - Renée Sabran

    Hyères, 83406, France

  • Hôpital Fondation Adolphe de Rothschild

    Paris, France

  • Hôpital Rothschild

    Paris, 75012, France

  • Pole St Hélier

    Rennes, 35043, France

  • SSR Val Rosay UGECAM

    Saint-Didier-au-Mont-d'Or, 69370, France

  • Ste Anne

    Paris, 75674, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.