Clinical trial NCT05224349: 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.
Official title: Effectiveness and Safety of SMART BoNT-A Therapy With Dysport® in Patients With Post-stroke Chronic Upper Limb Spasticity in Real-life Setting.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Post-Stroke Chronic Upper Limb Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2022-02-04
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with post-stroke chronic upper limb spasticity treated with Dysport® according to SMART guidelines.

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


Eligibility criteria: 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 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 Criteria:

* 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.

Primary outcomes:
measure: Change from baseline of Disability Assessment Scale (DAS) score in Principle Target of Treatment (PTT) for the upper limb.
timeFrame: At 12 weeks to 16 weeks after injection at Visit 1
Secondary outcomes:
measure: Change from baseline of Modified Ashworth Scale (MAS) Primary Target Muscle Group (PTMG)
timeFrame: At 12 weeks to 16 weeks
measure: Change from baseline of pain assessed with Visual Analogue Scale (VAS)
timeFrame: At 12 weeks to 16 weeks
measure: Change from baseline of Spasticity Related Quality of Life Tool (SQoL-6D)
timeFrame: At 12 weeks to 16 weeks
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 32 weeks
measure: Incidence of Special Situations (SS)
timeFrame: Up to 32 weeks
Other outcomes:
Locations:
city: Altdorf
country: Germany
facility: Nervenarztpraxis
city: Berlin
country: Germany
facility: Neurologisches Zentrum
city: Erding
country: Germany
facility: Neurozentrum Erding
city: Essen
country: Germany
facility: Praxis für Neurochirurgie und Schmerztherapie
city: Fürth
country: Germany
facility: Fürth; Medzentrum Fürth (MVZ)
city: Fürth
country: Germany
facility: Neuropraxis Fuerth
city: Fürth
country: Germany
facility: Neuropraxis Fürth
city: Gelsenkirchen
country: Germany
facility: Evangelisches Klinikum Gelsenkirchen GmbH
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Herford
country: Germany
facility: Herford; Klinikum Herford
city: Kiel
country: Germany
facility: Praxis Sojka-Raytscheff
city: Königs Wusterhausen
country: Germany
facility: Neurologie am Funkerberg
city: Landshut
country: Germany
facility: MVZ Lakumed gGMBH
city: Leipzig
country: Germany
facility: Praxis
city: Ludwigsburg
country: Germany
facility: Fuerth; Medzentrum Fuerth
city: Lübeck
country: Germany
facility: UK Schleswig-Holstein Campus Lübeck
city: Mannheim
country: Germany
facility: Neuropraxis Mannheim
city: München
country: Germany
facility: Neurozentrum Arabellapark
city: Nuremberg
country: Germany
facility: Nürnberg; Praxis
city: Nürnberg
country: Germany
facility: ABC Ambulantes BehandlungsCentrum GmbH
city: Nürnberg
country: Germany
facility: ABC Moegeldorf
city: Quickborn
country: Germany
facility: Gesundheitszentrum Quickborn
city: Rottach-Egern
country: Germany
facility: Medicum. tegernsee - Rottach-Weissach
city: Rottach
country: Germany
facility: Medicum. Tegernsee
city: Rülzheim
country: Germany
facility: ZNS Südpfalz
city: Solingen
country: Germany
facility: St. Lukas Klinik GmbH
city: Sonneberg
country: Germany
facility: Praxis
city: Stadtroda
country: Germany
facility: Stadtroda; Asklepios Fachklinikum Stadtroda
city: Straubing
country: Germany
facility: Gemeinschaftspraxis
city: Troisdorf
country: Germany
facility: MVZ Neurologie am St. Johannes Sieglar
city: Wuelfrath
country: Germany
facility: Neurologie im Denkmal
city: Wülfrath
country: Germany
facility: Neurologie im Denkmal
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: