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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's demographic data | Patient's Characteristics | through study completion, an average of 14 months |
| Caregiver's demographic data; | Patient's Characteristics |
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Inclusion Criteria:
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.
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Bagnères | Bagnères-de-Bigorre | 65201 | France | |||
| CH Bar le Duc |
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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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.
Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
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| through study completion, an average of 14 months |
| Aetiology of spasticity; | Patient's Characteristics | through study completion, an average of 14 months |
| Affected upper limb | Patient's Characteristics | through study completion, an average of 14 months |
| Ascribed spastic muscle group(s); | Patient's Characteristics | through study completion, an average of 14 months |
| Time since onset of the aetiology of upper limb spasticity (ULS) | Patient's Characteristics | through study completion, an average of 14 months |
| Associated lower limb spasticity (LLS) | Patient's Characteristics | through study completion, an average of 14 months |
| Global autonomy evaluation (modified Rankin Scale). | Patient's Characteristics | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | through study completion, an average of 26 months |
| Proportion of patients "attaining" the primary Goal | Treatment Effectiveness | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Up to 14 months |
| 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 |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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