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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

Full criteria on ClinicalTrials.gov

Sites (31)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nervenarztpraxis
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AltdorfGermanyUnknown status
Neurologisches Zentrum
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BerlinGermanyUnknown status
Neurozentrum Erding
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ErdingGermanyUnknown status
Praxis für Neurochirurgie und Schmerztherapie
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EssenGermanyUnknown status
Neuropraxis Fürth
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FürthGermanyUnknown status
Fürth; Medzentrum Fürth (MVZ)
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FürthGermanyUnknown status
Neuropraxis Fuerth
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FürthGermanyUnknown status
Evangelisches Klinikum Gelsenkirchen GmbH
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GelsenkirchenGermanyUnknown status
Universitätsmedizin Greifswald
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GreifswaldGermanyUnknown status
Herford; Klinikum Herford
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HerfordGermanyUnknown status
Praxis Sojka-Raytscheff
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KielGermanyUnknown status
Neurologie am Funkerberg
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Königs WusterhausenGermanyUnknown status
MVZ Lakumed gGMBH
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LandshutGermanyUnknown status
Praxis
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LeipzigGermanyUnknown status
UK Schleswig-Holstein Campus Lübeck
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LübeckGermanyUnknown status
Fuerth; Medzentrum Fuerth
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LudwigsburgGermanyUnknown status
Neuropraxis Mannheim
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MannheimGermanyUnknown status
Neurozentrum Arabellapark
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MünchenGermanyUnknown status
ABC Moegeldorf
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NurembergGermanyUnknown status
ABC Ambulantes BehandlungsCentrum GmbH
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NurembergGermanyUnknown status
Nürnberg; Praxis
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NurembergGermanyUnknown status
Gesundheitszentrum Quickborn
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QuickbornGermanyUnknown status
Medicum. Tegernsee
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RottachGermanyUnknown status
Medicum. tegernsee - Rottach-Weissach
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Rottach-EgernGermanyUnknown status
ZNS Südpfalz
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RülzheimGermanyUnknown status
St. Lukas Klinik GmbH
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SolingenGermanyUnknown status
Praxis
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SonnebergGermanyUnknown status
Stadtroda; Asklepios Fachklinikum Stadtroda
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StadtrodaGermanyUnknown status
Gemeinschaftspraxis
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StraubingGermanyUnknown status
MVZ Neurologie am St. Johannes Sieglar
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TroisdorfGermanyUnknown status
Neurologie im Denkmal
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WuelfrathGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.