Status:
COMPLETED
Effectiveness and Safety of SMART [Spastic Muscle Palpation by Anatomic Landscape for BoNT-A (Botulinumtoxin-A) Injection to Reduce Muscle Tone] BoNT-A Therapy With Dysport® in Patients With Post-stroke Chronic Upper Limb Spasticity (ULS) in Real-life Setting.
Lead Sponsor:
Ipsen
Conditions:
Post-Stroke Chronic Upper Limb Spasticity
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to collect data for Dysport® SMART BoNT-A therapy usage in an office-based setting in post-stroke participants with chronic (\> 6 months) focal Upper Limb Spasticity who h...
Eligibility Criteria
Inclusion
- Male or female patients ≥18 years with the capacity to consent.
- Subjects with a post-stroke medium to severe focal upper limb spasticity for at least 6 months. Medium to severe focal upper limb spasticity is defined as MAS ≥2 in the PTMG and DAS ≥2 in the PTT.
- Cohort according to SMART guidelines. The SMART injection concept is designed to be used only in patients suffering from simple patterns ("easy to diagnose spasticity pattern") of adult ULS, where Abobotulinumtoxin-A (AboBoNT-A) (Dysport®) injection can be simplified, by recognizing common spasticity patterns and key muscles for injection, identifying those muscles by palpation, and appropriate injection points of the suggested muscles using anatomic landmarks.
- Subjects with treatment goals as reduction of pain, reduction of muscle tone, improvement of care (hygiene/dressing) and/or improvement of passive motion.
- Subjects with the intention to be treated with Dysport® according to the current local Summary of Product Characteristics (SmPC) (Germany) and injection according to SMART must be taken prior to the entry in the study.
- Physiotherapy should remain unchanged within 4 weeks before study start.
Exclusion
- Patients treated with intrathecal Baclofen or BoNT-A within the last 6 months
- If treated with oral spasticity medication, change of oral spasticity medication within the last 4 weeks
- Patients with active hand functions or patients with treatment goals of active functions.
- Patients with any contraindication for Dysport® according to SmPC.
- Patients in whom SMART therapy is not appropriate (e.g. spasticity pattern other than specified in SMART guidelines).
- Participation in an interventional trial at the same time and/or within 3 months before baseline.
- Diagnosed contracture/contracted muscle.
Key Trial Info
Start Date :
May 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 4 2025
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT05224349
Start Date
May 9 2022
End Date
July 4 2025
Last Update
August 1 2025
Active Locations (31)
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1
Nervenarztpraxis
Altdorf, Germany
2
Neurologisches Zentrum
Berlin, Germany
3
Neurozentrum Erding
Erding, Germany
4
Praxis für Neurochirurgie und Schmerztherapie
Essen, Germany