Study to compare the effect of two different injection techniques used for Dysport treatment of patients with upper limb spasticity post stroke or traumatic brain injury

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 272

Inclusion Criteria

o Provision of written informed consent prior to any study related procedures,
o Subjects male or female, aged 18 or older,
o Upper limb spasticity post stroke or traumatic brain injury,
o Spasticity position pattern type 1, 3 or 4,
o Elbow flexor muscles spasticity MAS 2 to 3,
o At least 2 consecutive previous treatment cycles of BoNT-A for current diagnosis,
o The latest treatment cycle demonstrating good treatment efficacy where the Dysport dose administered was considered to be adequate according to Investigator judgement,
oNeed of the same treatment modality in m. brachialis, m. biceps brachii, m. brachioradialis, m. flex. carpi ulnaris, m. flex. carpi radialis as the previous treatment cycle,
o Last BoNT-A treatment 12-24 weeks ago
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

Subjects will not be included in the study if they meet any or the following criteria:
• Poor response to BoNT-A treatment, according to Investigator,
• Need of Dysport doses >800U in the upper limb,
• Concomitant treatment with BoNT-A for other indications than spasticity,
• Any elbow flexor contracture prohibiting MAS evaluation and/or elbow flexion improvement of at least 1 step on the MAS
• Cutaneous or joint inflammation in the affected upper limb,
• Is likely to start other spasticity treatment during the study,
• Is likely to start physiotherapy treatment during the study,
• Other ongoing neurological disorder (e.g., myasthenia gravis),
• History of dysphagia or aspiration,
• Use of agents interfering with neuromuscular transmission (e.g., aminoglycosides),
• Treated with an investigational medicinal product within 30 days before start of the study,
• Known sensitivity to BoNT-A or any components of Dysport,
• Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test (U-hCG) at visit 1 and must be using adequate contraception. Non childbearing potential is defined as post-menopause for at least one year, surgical sterilisation or hysterectomy at least three months before the start of the study,
• Has a history of, or known current, problems with alcohol or drug abuse,
• Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude,
• Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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