Study to Evaluate Effects of DYSPORT® Injected in Lower and Upper Limb Combined With Guided Self-Rehabilitation Contract (GSC)
Condition: Spastic Hemiparesis
MeSH terms: Muscle Spasticity; Paresis
Intervention: Botulinum toxin type A; GSC
Intervention description: Dysport® administered in both upper and lower limbs (total dose of 1500 U per injection split between the 2 limbs).; The GSC is a motivational tool. The physiotherapist will teach each subject the stretching postures and exercises to perform on a daily basis throughout the study. These will be tailored to the individual subject's needs and will form the GSC therapy.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®)
      injections in upper and lower limbs accompanied with a personal exercise plan called "Guided
      Self-rehabilitation Contract" (GSC) can improve voluntary movements in subjects with
      hemiparesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged at least the national legal adult age.

          -  Subjects with hemiparesis due to acquired brain injury (ABI) presenting with muscle
             overactivity impeding motor function based on investigator's judgement including, but
             not limited to, at least one of the following requiring botulinum neurotoxin (BoNT)
             treatment: typical clenched fist; flexed wrist; flexed elbow; or plantar flexed foot
             pattern.

          -  At least 12 months since the ABI (i.e. stroke or traumatic brain injury (TBI)).

          -  Naïve or non-naïve to BoNT treatment; if non-naïve, at least 4 months after the last
             BoNT injection, of any serotype.

          -  Upper limb active function with an overall score between 2 and 7, as assessed by
             Modified Frenchay Scale (MFS), if the primary TT limb is the upper limb (UL).

          -  A 10-metre maximal WS barefoot between 0.2 and 1.4 m/s, if the primary TT limb is the
             lower limb (LL). Maximal WS barefoot will be performed without walking aids. However,
             a cane may be permitted if absolutely necessary (although this may prevent detection
             of treatment-induced improvements). In this case, the same aid will have to be used
             for all WS assessments during the study.

          -  Subjects must provide written informed consent to participate in the study prior to
             any study-related procedures.

          -  Female subjects of childbearing potential (not surgically sterile or 2 years
             postmenopausal) must use a medically accepted method of contraception and must agree
             to continue use of this method for the duration of the study until the last visit of
             the subjects and for at least 12 weeks post injection. Acceptable methods of
             contraception include total abstinence, male partner has had a vasectomy, double
             barrier method (e.g. male condom plus spermicide, or female diaphragm plus
             spermicide), intrauterine device, or hormonal contraceptive (oral, transdermal,
             implanted and injected).

          -  Subjects must be willing and able to comply with study restrictions and to remain at
             the clinic for the required duration during the study period and willing to return to
             the clinic for the follow-up evaluation as specified in the protocol

        Exclusion Criteria:

          -  Inability to understand protocol procedures and requirements, which, in the opinion of
             the investigator, could negatively impact on protocol compliance, in particularly
             inability to exercise according to the GSC.

          -  Previous surgery on the affected muscles and ligaments, tendons, nerve trunks, or
             bones of the treated upper or lower limb.

          -  Previous treatment with phenol and/or alcohol in any of the treated limbs any time
             before the study.

          -  Any medical condition (including severe dysphagia or breathing difficulties) that may
             increase, in the opinion of the investigator, the likelihood of adverse events (AEs)
             related to BoNT A treatment.

          -  Current, planned or received within the last 4 weeks prior to study treatment,
             treatment with any drug that interferes either directly or indirectly with
             neuromuscular function (for example, aminoglycosides).

          -  Major neurological impairment other than spastic paresis (including major
             proprioceptive ataxia or apraxia on the paretic side) that could negatively impact on
             the functional performance of the subject.

          -  Known disease of the neuromuscular junction (such as Lambert-Eaton myasthenic syndrome
             or myasthenia gravis).

          -  Known sensitivity to BoNT-A or any excipient of Dysport.

          -  Infection at the injection site(s).

          -  Current pregnancy or lactation. A pregnancy test will be performed at the start of the
             study for all female subjects of childbearing potential (i.e. not surgically sterile
             or 2 years postmenopausal).

          -  Mental condition rendering the subject unable to understand the nature, scope and
             possible consequences of the study and/or evidence of an uncooperative attitude.

          -  Abnormal baseline findings or any other medical condition(s) that, in the opinion of
             the investigator, might jeopardise the subject's safety.

          -  Subjects treated, or likely to be treated, with intrathecal baclofen during the course
             of the study or during the 4 weeks before study entry.

          -  Subjects who have participated in any therapeutic clinical study/received any
             investigational agent within 30 days of enrolment.