Study to Evaluate Effects of DYSPORT® Injected in Lower and Upper Limb Combined With Guided Self-Rehabilitation Contract (GSC)



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:12/15/2018
Start Date:December 18, 2016
End Date:July 2018

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An International, Multicentre, Prospective, Single-Arm Study to Assess the Effect on Voluntary Movements of AbobotulinumtoxinA 1500 U Administered in Both Upper and Lower Limbs in Conjunction With a Guided Self-Rehabilitation Contract in Adult Subjects With Spastic Hemiparesis

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.


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 MFS,
if the primary TT limb is the UL.

- A 10-metre maximal WS barefoot between 0.2 and 1.4 m/s, if the primary TT limb is the
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.
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