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.

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Stroke Chronic Upper Limb Spasticity

• Study Type: Observational
• Enrollment (Estimated): 116

Contacts and Locations

• Study Contact: Name: Ipsen Recruitment Enquiries; Phone Number: See email; Email: clinical.trials@ipsen.com

Study Locations

• Germany
  • Altdorf, Germany
    • Recruiting
    • Nervenarztpraxis
  • Berlin, Germany
    • Not yet recruiting
    • Neurologisches Zentrum
  • Erding, Germany
    • Not yet recruiting
    • Neurozentrum Erding
  • Essen, Germany
    • Recruiting
    • Praxis für Neurochirurgie und Schmerztherapie
  • Fürth, Germany
    • Not yet recruiting
    • Neuropraxis Fürth
  • Fürth, Germany
    • Recruiting
    • Fürth; Medzentrum Fürth (MVZ)
  • Fürth, Germany
    • Recruiting
    • Neuropraxis Fuerth
  • Gelsenkirchen, Germany
    • Recruiting
    • Evangelisches Klinikum Gelsenkirchen GmbH
  • Greifswald, Germany
    • Recruiting
    • Universitätsmedizin Greifswald
  • Herford, Germany
    • Recruiting
    • Herford; Klinikum Herford
  • Kiel, Germany
    • Not yet recruiting
    • Praxis Sojka-Raytscheff
  • Königs Wusterhausen, Germany
    • Recruiting
    • Neurologie am Funkerberg
  • Landshut, Germany
    • Recruiting
    • MVZ Lakumed gGMBH
  • Leipzig, Germany
    • Recruiting
    • Praxis
  • Ludwigsburg, Germany
    • Recruiting
    • Fuerth; Medzentrum Fuerth
  • Lübeck, Germany
    • Recruiting
    • UK Schleswig-Holstein Campus Lübeck
  • Mannheim, Germany
    • Recruiting
    • Neuropraxis Mannheim
  • München, Germany
    • Recruiting
    • Neurozentrum Arabellapark
  • München, Germany
    • Withdrawn
    • Praxis
  • Nuremberg, Germany
    • Not yet recruiting
    • Nürnberg; Praxis
  • Nürnberg, Germany
    • Not yet recruiting
    • ABC Ambulantes BehandlungsCentrum GmbH
  • Nürnberg, Germany
    • Recruiting
    • ABC Moegeldorf
  • Quickborn, Germany
    • Recruiting
    • Gesundheitszentrum Quickborn
  • Rottach, Germany
    • Not yet recruiting
    • Medicum. Tegernsee
  • Rottach-Egern, Germany
    • Recruiting
    • Medicum. tegernsee - Rottach-Weissach
  • Rülzheim, Germany
    • Recruiting
    • ZNS Südpfalz
  • Solingen, Germany
    • Recruiting
    • St. Lukas Klinik GmbH
  • Sonneberg, Germany
    • Not yet recruiting
    • Praxis
  • Stadtroda, Germany
    • Not yet recruiting
    • Stadtroda; Asklepios Fachklinikum Stadtroda
  • Straubing, Germany
    • Recruiting
    • Gemeinschaftspraxis
  • Troisdorf, Germany
    • Recruiting
    • MVZ Neurologie am St. Johannes Sieglar
  • Wuelfrath, Germany
    • Recruiting
    • Neurologie im Denkmal
  • Wülfrath, Germany
    • Not yet recruiting
    • Neurologie im Denkmal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with post-stroke chronic upper limb spasticity treated with Dysport® according to SMART guidelines.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group A; Participants with stable oral anti-spasticity treatment for at least 4 weeks prior to study entry
Group B; Participants with no anti-spasticity therapy for at least 4 weeks prior to study entry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of Disability Assessment Scale (DAS) score in Principle Target of Treatment (PTT) for the upper limb.	The PTT will be pre-selected from the 4 DAS domains: hygiene, dressing, limb position and pain of the upper limb at Visit 1. The extent of functional impairment in the PTT will be assessed on a four-point scale (range 0 to 3, where 0=no disability, and 3=severe disability) at each visit.	At 12 weeks to 16 weeks after injection at Visit 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of Modified Ashworth Scale (MAS) Primary Target Muscle Group (PTMG)	Muscle tone will be evaluated using the MAS. The PTMG (shoulder adductors, elbow flexors, wrist flexors or finger flexors) will be pre-selected at Visit 1. The muscle tone in the PTMG will be assessed from 0 (no increase in tone) to 4 (affected part(s) rigid in flexion or extension) at each visit.	At 12 weeks to 16 weeks
Change from baseline of pain assessed with Visual Analogue Scale (VAS)	Pain (from 0 (no pain) to 10 (maximum pain) in upper limb extremity will be assessed at each visit.	At 12 weeks to 16 weeks
Change from baseline of Spasticity Related Quality of Life Tool (SQoL-6D)	The questionnaire covers six dimensions: Pain/ discomfort, involuntary movement or spasms, restricted range of movement, caring for the affected limb, using the affected limb, mobility/balance. Each dimension is assessed using a five-point scale ranging from 0 to 4, with higher scores meaning worse outcome.	At 12 weeks to 16 weeks
Incidence of Adverse Events (AEs)		Up to 32 weeks
Incidence of Special Situations (SS)		Up to 32 weeks

Collaborators and Investigators

• Sponsor: Ipsen
• Investigators: Study Director: Ipsen Medical Director, Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity
• Other Study ID Numbers: CLIN-52120-456

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

• IPD Sharing Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• IPD Sharing Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No