Effectiveness and Safety of SMART [Spastic Muscle Palpati... | NCT05224349

Studies
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.

NCT05224349

Sponsor

Ipsen

Status

Completed

Last Update Posted

Aug 1, 2025Actual

Enrollment

121Actual

Phase

Not provided

Conditions

Post-Stroke Chronic Upper Limb Spasticity

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
EUPAS107722	Other Identifier	EMA RWC

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 9, 2022Actual

Primary Completion Date

Apr 9, 2025Actual

Completion Date

Jul 4, 2025Actual

First Submitted Date

Jan 25, 2022

First Submission Date that Met QC Criteria

Jan 25, 2022

First Posted Date

Feb 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2025

Last Update Posted Date

Aug 1, 2025Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Label	Type	Description	Intervention Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Ipsen Medical Director	Ipsen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Nervenarztpraxis		Altdorf			Germany
Neurologisches Zentrum

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Not provided

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.

Access Criteria

Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

URL

https://vivli.org/members/ourmembers/