Phase III, multicentre study assesssing the long term safety and and efficay of repeated treatments with Dysport in the treatment of leg spasticity in adult patients with hemiparesis.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 385

Inclusion Criteria

Subjects who have completed the double blind study (Study 140), up to the Week 12, Week 16, Week 20 or Week 24 follow up visit, and who do not have any major protocol deviation and/or any ongoing AEs (either of which, in the opinion of the Investigator, would pose an unacceptable risk to the subjects were they to continue receiving treatment) will be eligible for the study. Additionally, an informed consent for this open label extension study will be signed.
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 297
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 88

Exclusion Criteria

•Major limitation in the passive range of motion at the affected hip, knee or ankle, as defined by:
°maximum passive hip flexion (knee flexed) < 30º,
°maximum passive knee flexion (hip flexed) < 70º,
°maximum passive ankle dorsiflexion (knee flexed) < 10º,
°maximum passive knee extension < 160º.
•Previous surgery to treat spasticity on the affected muscles and ligaments, tendons or nerve trunks of the treated lower limb.
•Previous treatment with phenol and/or alcohol in the treated lower limb at any time before the study.
•Cognitive impairment altering the capacity to comply with the trial according to Investigator’s judgement.
•Severe neurological impairment (not associated with the stroke or brain trauma) due to an underlying neuromuscular disease or any other underlying disease or condition affecting gait (for example, Multiple Sclerosis).
•Known disease of the neuromuscular junction (such as Lambert Eaton myasthenic syndrome or myasthenia gravis).
•Unwillingness or inability to comply with the protocol.
•Major hypoaesthesia or ataxia on the paretic side.
•Known sensitivity to Botulinum toxin (BTX) or any Dysport excipients.
•Infection at the injection site(s).
•Current or planned treatment with any drug that interferes either directly or indirectly with neuromuscular function (for example, aminoglycosides) within the last 4 weeks prior to study treatment.
•Pregnant women, or premenopausal women not willing to use contraceptive measures throughout the duration of the study.
•Treatment with a new investigational drug within 4 weeks prior to enrolment into the study or scheduled treatment with such a drug during the study period.
•Any medical condition (or laboratory finding), that in the opinion of the Investigator may compromise compliance with the objectives and/or procedures of this protocol or preclude the administration of BTX.
•Subjects treated or likely to be treated with
intrathecal baclofen during the course of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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