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.

Ipsen

Status: Active, not recruiting

Conditions: Post-Stroke Chronic Upper Limb Spasticity

Study type: Observational

Funder types: Industry

Identifiers

NCT05224349

CLIN-52120-456

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

121 participants in 2 patient groups

Group A

Description:

Participants with stable oral anti-spasticity treatment for at least 4 weeks prior to study entry

Group B

Description:

Participants with no anti-spasticity therapy for at least 4 weeks prior to study entry