Phase III, multicentre study assessing the long term safety and efficacy of repeated treatments with Dysport in the treatment of arm spasticity in adult patients with hemiparesis.

• Conditions: Arm spasticity; MedDRA version: 16.1Level: LLTClassification code 10048970Term: Arm spasticitySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-019162-83-PL
• Lead Sponsor: Ipsen Innovation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-04
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

Subjects who have completed the double blind study (Study 145) up to the Week 12, Week 16, Week 20 or Week 24 follow up visit will be eligible for this open label extension study.
De novo subjects must satisfy all of the following inclusion criteria to be eligible for the study :
(1) Provision of written informed consent prior to any study related procedures.
(2) Subjects with hemiparesis and aged between 18 and 80 years, inclusive.
(3) Subjects who had one clinically defined stroke episode, as defined by the World Health Organisation (WHO) criteria or who have had one brain trauma, or subjects who had a nonevolutive lesion diagnosed prior to the stroke and in the same hemisphere as shown by brain imaging (i.e. scan or MRI).
(4) At least 6 months post-stroke or traumatic brain injury.
(5) Modified Ashworth Scale (MAS) score =2 in the primary targeted muscle group for toxin naïve subjects or MAS score =3 in the primary targeted muscle group for toxin non-naïve subjects at least 4 months after the last BTX injection, of any serotype. Please note that for the purpose of this protocol, a naïve subject is defined as a subject who has never received any BTX in the affected upper limb.
(6) Disability Assessment Scale (DAS) score =2 on the PTT.
(7) Spasticity angle =10° in the primary targeted muscle group.
(8) Modified Frenchay Scale (MFS) overall score (average of all task scores) between 1 and 8 (including limit values).
(9) Subjects able to receive 1000 U in their upper limb at Treatment Cycle 1.

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 194
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

Subjects (both rollover and de novo) are not be excluded if any of the following apply:
•Major limitation in the passive ROM at the affected wrist, fingers and elbow, as defined by:
oMaximum passive elbow extension <150º (0º corresponding to the minimal stretch of the elbow flexors, which corresponds to a fully flexed elbow position).
oMaximum passive wrist extension <70º (0º corresponding to the minimal stretch of the wrist flexors, which corresponds to a fully flexed wrist position).
oMaximum passive finger extension <70º (0º corresponding to the minimal stretch of the extrinsic finger flexors, which corresponds to a formed fist with the second phalanx parallel to the metacarpal).
•Previous surgery to treat spasticity of the affected upper limb.
•Previous treatment with phenol and/or alcohol in the treated upper limb anytime before the study.
•Any medical condition (including severe dysphagia or airway disease) that may increase, in the opinion of the Investigator, the likelihood of AEs related to botulinum toxin (BTX) treatment.
•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).
•Inability to understand protocol procedures and requirements which, in the opinion of the Investigator, could negatively impact on protocol compliance.
•Known sensitivity to BTX or any excipients of Dysport.
•Infection at the injection site(s).
•Unwillingness or inability to comply with the protocol.
•Current or planned treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. 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 in the 4 weeks prior to enrolment into the study or scheduled to receive such a drug during the study period.
•Any underlying disease (not associated with the stroke or brain trauma) likely to affect upper limb function and/or muscle tone and/or spasticity.
•Any medical condition (or laboratory finding), which 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
De novo subjects are to be excluded if any of the following additional criteria apply:
(1) Physiotherapy initiated less than 4 weeks before entry or expected to be initiated during the study.
(2) Previous treatment with BTX of any type within 4 months prior to study entry for any condition.
(3) Previous primary or secondary non response to any BTXs for the targeted condition.

Study & Design

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