NCT05224349Completed
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.
Effectiveness and Safety of SMART BoNT-A Therapy With Dysport® in Patients With Post-stroke Chronic Upper Limb Spasticity in Real-life Setting.
Source: ClinicalTrials.gov · Last updated 1 Aug 2025
Brief summary (registry, in English)
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 have been under stable oral antispastics treatment or patients with no current anti-spasticity treatment.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 121 (actual)
- First submitted
- 25 Jan 2022
- Start date
- 9 May 2022
- Primary completion date
- 9 Apr 2025
- Lead sponsor
- Ipsen
- Diseases
- Stroke
- NCT number
- NCT05224349
What you commit to
- Study type: Observational
- Participants enrolled: 121
- From 9 May 2022 to the primary completion date, 9 Apr 2025
- 31 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.
Other
- Patients with active hand functions or patients with treatment goals of active functions.
- Patients with any contraindication for Dysport® according to SmPC.
- Diagnosed contracture/contracted muscle.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (31)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nervenarztpraxis Coordinator of this site? Confirm its status | Altdorf | Germany | Unknown status |
| Neurologisches Zentrum Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Neurozentrum Erding Coordinator of this site? Confirm its status | Erding | Germany | Unknown status |
| Praxis für Neurochirurgie und Schmerztherapie Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Neuropraxis Fürth Coordinator of this site? Confirm its status | Fürth | Germany | Unknown status |
| Fürth; Medzentrum Fürth (MVZ) Coordinator of this site? Confirm its status | Fürth | Germany | Unknown status |
| Neuropraxis Fuerth Coordinator of this site? Confirm its status | Fürth | Germany | Unknown status |
| Evangelisches Klinikum Gelsenkirchen GmbH Coordinator of this site? Confirm its status | Gelsenkirchen | Germany | Unknown status |
| Universitätsmedizin Greifswald Coordinator of this site? Confirm its status | Greifswald | Germany | Unknown status |
| Herford; Klinikum Herford Coordinator of this site? Confirm its status | Herford | Germany | Unknown status |
| Praxis Sojka-Raytscheff Coordinator of this site? Confirm its status | Kiel | Germany | Unknown status |
| Neurologie am Funkerberg Coordinator of this site? Confirm its status | Königs Wusterhausen | Germany | Unknown status |
| MVZ Lakumed gGMBH Coordinator of this site? Confirm its status | Landshut | Germany | Unknown status |
| Praxis Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| UK Schleswig-Holstein Campus Lübeck Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Fuerth; Medzentrum Fuerth Coordinator of this site? Confirm its status | Ludwigsburg | Germany | Unknown status |
| Neuropraxis Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Neurozentrum Arabellapark Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| ABC Moegeldorf Coordinator of this site? Confirm its status | Nuremberg | Germany | Unknown status |
| ABC Ambulantes BehandlungsCentrum GmbH Coordinator of this site? Confirm its status | Nuremberg | Germany | Unknown status |
| Nürnberg; Praxis Coordinator of this site? Confirm its status | Nuremberg | Germany | Unknown status |
| Gesundheitszentrum Quickborn Coordinator of this site? Confirm its status | Quickborn | Germany | Unknown status |
| Medicum. Tegernsee Coordinator of this site? Confirm its status | Rottach | Germany | Unknown status |
| Medicum. tegernsee - Rottach-Weissach Coordinator of this site? Confirm its status | Rottach-Egern | Germany | Unknown status |
| ZNS Südpfalz Coordinator of this site? Confirm its status | Rülzheim | Germany | Unknown status |
| St. Lukas Klinik GmbH Coordinator of this site? Confirm its status | Solingen | Germany | Unknown status |
| Praxis Coordinator of this site? Confirm its status | Sonneberg | Germany | Unknown status |
| Stadtroda; Asklepios Fachklinikum Stadtroda Coordinator of this site? Confirm its status | Stadtroda | Germany | Unknown status |
| Gemeinschaftspraxis Coordinator of this site? Confirm its status | Straubing | Germany | Unknown status |
| MVZ Neurologie am St. Johannes Sieglar Coordinator of this site? Confirm its status | Troisdorf | Germany | Unknown status |
| Neurologie im Denkmal Coordinator of this site? Confirm its status | Wuelfrath | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.