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.

Last updated: April 29, 2025
Sponsor: Ipsen
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Limb Spasticity

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT05224349
CLIN-52120-456
  • Ages > 18
  • All Genders

Study 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 have been under stable oral antispastics treatment or patients with no current anti-spasticity treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female patients ≥18 years with the capacity to consent.

  • Subjects with a post-stroke medium to severe focal upper limb spasticity for atleast 6 months. Medium to severe focal upper limb spasticity is defined as MAS ≥2 inthe PTMG and DAS ≥2 in the PTT.

  • Cohort according to SMART guidelines. The SMART injection concept is designed to beused only in patients suffering from simple patterns ("easy to diagnose spasticitypattern") of adult ULS, where Abobotulinumtoxin-A (AboBoNT-A) (Dysport®) injectioncan be simplified, by recognizing common spasticity patterns and key muscles forinjection, identifying those muscles by palpation, and appropriate injection pointsof 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 currentlocal Summary of Product Characteristics (SmPC) (Germany) and injection according toSMART must be taken prior to the entry in the study.

  • Physiotherapy should remain unchanged within 4 weeks before study start.

Exclusion

Exclusion Criteria:

  • Patients treated with intrathecal Baclofen or BoNT-A within the last 6 months

  • If treated with oral spasticity medication, change of oral spasticity medicationwithin the last 4 weeks

  • Patients with active hand functions or patients with treatment goals of activefunctions.

  • Patients with any contraindication for Dysport® according to SmPC.

  • Patients in whom SMART therapy is not appropriate (e.g. spasticity pattern otherthan specified in SMART guidelines).

  • Participation in an interventional trial at the same time and/or within 3 monthsbefore baseline.

  • Diagnosed contracture/contracted muscle.

Study Design

Total Participants: 121
Study Start date:
May 09, 2022
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Nervenarztpraxis

    Altdorf,
    Germany

    Site Not Available

  • Neurologisches Zentrum

    Berlin,
    Germany

    Site Not Available

  • Neurozentrum Erding

    Erding,
    Germany

    Site Not Available

  • Praxis für Neurochirurgie und Schmerztherapie

    Essen,
    Germany

    Site Not Available

  • Fürth; Medzentrum Fürth (MVZ)

    Fürth,
    Germany

    Site Not Available

  • Neuropraxis Fuerth

    Fürth,
    Germany

    Site Not Available

  • Neuropraxis Fürth

    Fürth,
    Germany

    Site Not Available

  • Evangelisches Klinikum Gelsenkirchen GmbH

    Gelsenkirchen,
    Germany

    Site Not Available

  • Universitätsmedizin Greifswald

    Greifswald,
    Germany

    Site Not Available

  • Herford; Klinikum Herford

    Herford,
    Germany

    Site Not Available

  • Praxis Sojka-Raytscheff

    Kiel,
    Germany

    Site Not Available

  • Neurologie am Funkerberg

    Königs Wusterhausen,
    Germany

    Site Not Available

  • MVZ Lakumed gGMBH

    Landshut,
    Germany

    Site Not Available

  • Praxis

    Leipzig,
    Germany

    Site Not Available

  • Fuerth; Medzentrum Fuerth

    Ludwigsburg,
    Germany

    Site Not Available

  • UK Schleswig-Holstein Campus Lübeck

    Lübeck,
    Germany

    Site Not Available

  • Neuropraxis Mannheim

    Mannheim,
    Germany

    Site Not Available

  • Neurozentrum Arabellapark

    München,
    Germany

    Site Not Available

  • Praxis

    München,
    Germany

    Site Not Available

  • Nürnberg; Praxis

    Nuremberg,
    Germany

    Site Not Available

  • ABC Ambulantes BehandlungsCentrum GmbH

    Nürnberg,
    Germany

    Site Not Available

  • ABC Moegeldorf

    Nürnberg,
    Germany

    Site Not Available

  • Gesundheitszentrum Quickborn

    Quickborn,
    Germany

    Site Not Available

  • Medicum. Tegernsee

    Rottach,
    Germany

    Site Not Available

  • Medicum. tegernsee - Rottach-Weissach

    Rottach-Egern,
    Germany

    Site Not Available

  • Medicum. tegernsee

    Rottach-Weissach,
    Germany

    Site Not Available

  • ZNS Südpfalz

    Rülzheim,
    Germany

    Site Not Available

  • St. Lukas Klinik GmbH

    Solingen,
    Germany

    Site Not Available

  • Praxis

    Sonneberg,
    Germany

    Site Not Available

  • Stadtroda; Asklepios Fachklinikum Stadtroda

    Stadtroda,
    Germany

    Site Not Available

  • Gemeinschaftspraxis

    Straubing,
    Germany

    Site Not Available

  • MVZ Neurologie am St. Johannes Sieglar

    Troisdorf,
    Germany

    Site Not Available

  • Neurologie im Denkmal

    Wuelfrath,
    Germany

    Site Not Available

  • Neurologie im Denkmal

    Wülfrath,
    Germany

    Site Not Available

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