Spastic Hemiparesis MedDRA version: 20.0 Level: LLT Classification code 10058978 Term: Spastic hemiparesis System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Dysport®
Pharmaceutical Form: Powder for solution for injection
CAS Number: 93384-43-1
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentration type: equa
Sponsors
Ipsen Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects aged at least the national legal adult age. 2) Subjects with hemiparesis due to ABI (i.e. stroke or traumatic brain injury (TBI)) 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. 3) At least 12 months since the ABI. 4) Naïve or non-naïve to BoNT treatment; if non-naïve, at least 4 months after the last BoNT injection, of any serotype. 5) Upper limb active function with an overall score between 2 and 7, as assessed by MFS locally rated score, if the primary TT limb is the UL. 6) 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. 7) Subjects must provide written informed consent to participate in the study prior to any study-related procedures. 8) 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).. 9) 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 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 119 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: 1) 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. 2) Previous surgery on the affected muscles and ligaments, tendons, nerve trunks, or bones of the treated upper or lower limb. 3) Previous treatment with phenol and/or alcohol in any of the treated limbs any time before the study. 4) 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. 5) Subjects treated, or likely to be treated, with intrathecal baclofen during the course of the study or during the 4 weeks before study entry. 6) 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). 7) 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. 8) Known disease of the neuromuscular junction (such as Lambert-Eaton myasthenic syndrome or myasthenia gravis). 9) Known sensitivity to BoNT-A or any excipient of Dysport. 10) Infection at the injection site(s). 11) 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). 12) Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude. 13) Abnormal baseline findings or any other medical condition(s) that, in the opinion of the investigator, might jeopardise the subject’s safety. 14) Subjects who have participated in any therapeutic clinical study/received any investigational agent within 30 days of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the responder rate as defined by the improvement of composite active range of motion (AROM) in the primary targeted limb, either upper limb (UL) or lower limb (LL), depending on which one has been selected as a primary treatment target (TT), following two consecutive AbobotulinumtoxinA injections combined with a Guided Self rehabilitation Contract (GSC) in subjects with spastic hemiparesis following acquired brain injury (ABI).;Secondary Objective: The secondary objectives are as follows: - to assess the effectiveness of AbobotulinumtoxinA combined with a GSC on: - to assess subject satisfaction with regard to the use of a GSC - to measure the changes in subject and physiotherapist beliefs that a GSC will help to improve function - to assess subject compliance with the GSC - to assess global benefits by both the investigator and the subject (or caregiver) - in subjects not reinjected at Week 12, to assess satisfaction with longer than 12 weeks interval between 2 injections - to assess health-related quality of life - to assess safety parameters;Primary end point(s): The primary efficacy endpoint is the percentage of responder subjects at Week 6 after the second injection, according to composite AROM in the primary TT limb.;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint is the percentage of responder subjects at Week 6 after the second injection, according to composite AROM in the primary TT limb. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The first secondary efficacy endpoints is the percentage of responder subjects at Week 6 after the first injection, according to composite AROM in the primary TT limb. ;Timepoint(s) of evaluation of this end point: The first secondary efficacy endpoints is the percentage of responder subjects at Week 6 after the first injection, according to composite AROM in the primary TT limb. | — |
Countries
Czech Republic, France, Russian Federation, United States
Contacts
Public ContactJovita Balcaitiene
Ipsen Pharma SAS
Outcome results
None listed