Comparing Lower-concentration Dysport Treatment Targeted to the Neuromuscular Junction With Current Clinical Practice
Condition: Arm Spasticity
MeSH terms: Muscle Spasticity
Intervention: Botulinum toxin type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dysport; arm spasticity; Modified Ashworth Scale; neuromuscular junction; Botulinum toxin; upper limb spasticity

Summary:

      The aim of the study was to compare Dysport treatment results (as assessed by Modified
      Ashworth Scale (MAS) in the elbow joint 4 weeks post treatment) following two treatment
      techniques: the current clinical practice injection technique using high-concentration
      dilution (300 U/mL Dysport) versus the neuromuscular junction (NMJ)-targeted injection
      technique using low-concentration dilution (100 U/mL Dysport). The hypothesis was that one
      high-volume, low-concentration injection located centrally in the area/band of the NMJ zones
      would be as effective as the technique used in current medical practice.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent prior to any study related procedures.

          -  Subjects male or female, aged 18 years or older.

          -  Upper limb spasticity post stroke or traumatic brain injury.

          -  Spasticity position pattern type 1, 3 or 4.

          -  Elbow flexor muscles spasticity MAS 2 to 3.

          -  At least 2 consecutive previous treatment cycles of BoNT-A for current diagnosis.

          -  The latest treatment cycle demonstrating good treatment efficacy where the Dysport
             dose administered was considered to be adequate according to Investigator judgement.

          -  Need of the same treatment modality in muscle (m.) brachialis, m. biceps brachii, m.
             brachioradialis, m. flexor carpi ulnaris, m. flexor carpi radialis as the previous
             treatment cycle.

          -  Last BoNT-A treatment 12-24 weeks ago.

        Exclusion Criteria:

          -  Poor response to BoNT-A treatment, according to Investigator.

          -  Need of Dysport doses >800 U 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.

          -  Was likely to start other spasticity treatment during the study.

          -  Was 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.

          -  Was at risk of pregnancy or was lactating. Females of childbearing potential must have
             provided a negative pregnancy test (urinary human chorionic gonadotropin (U-hCG)) at
             Visit 1 and must have been using adequate contraception. Non-childbearing potential
             was defined as post-menopause for at least one year, surgical sterilisation or
             hysterectomy at least three months before the start of the study.

          -  Had a history of, or known current, problems with alcohol or drug abuse.

          -  Had 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.

          -  Had abnormal Baseline findings, any other medical condition(s) or laboratory findings
             that, in the opinion of the investigator, might have jeopardised the subject's safety
             or decreased the chance of obtaining satisfactory data needed to achieve the
             objective(s) of the study.