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

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; Spastic Hemiparesis; MedDRA version: 19.1 Level: LLT Classification code 10058978 Term: Spastic hemiparesis System Organ Class: 100000004852

• Registration Number: EUCTR2016-001989-29-FR
• Lead Sponsor: Ipsen Pharma SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-12
• Study Completion: 2018-07-18
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 157

Inclusion Criteria

1) Subjects aged at least the national legal adult age.
2) Subjects with hemiparesis due to 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.
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, 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

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) 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).
6) 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.
7) Known disease of the neuromuscular junction (such as Lambert-Eaton myasthenic syndrome or myasthenia gravis).
8) Known sensitivity to BoNT-A or any excipient of Dysport.
9) Infection at the injection site(s).
10) 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).
11) Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
12) Abnormal baseline findings or any other medical condition(s) that, in the opinion of the investigator, might jeopardise the subject’s safety.
13) Anticoagulant treatment with international normalised ratio (INR) >3.5 within a week prior to injection.
14) Subjects who have participated in any therapeutic clinical study/received any investigational agent within 30 days of enrolment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified