Phase III, multicentre study assessing the efficacy and safety of Dysport compared to a Placebo for the treatment of upper limb spasticity in adult patients with hemiparesis.

• Register: EUCTR
• Last refreshed on: 30 September 2013
• Main ID: EUCTR2010-019069-28-HU
• Date of registration: 06/09/2012
• Prospective Registration: No
• Primary sponsor: Ipsen Innovation
• Public title: Phase III, multicentre study assessing the efficacy and safety of Dysport compared to a Placebo for the treatment of upper limb spasticity in adult patients with hemiparesis.
• Scientific title: A phase III, multicentre, prospective, double blind, randomised, placebo controlled study, assessing the efficacy and safety of Dysport intramuscular injections used for the treatment of upper limb spasticity in adult subjects with spastic hemiparesis due to stroke or traumatic brain injury.
• Date of first enrolment: 05/09/2012
• Target sample size: 228
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019069-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Czech Republic, Hungary, Italy, Poland, Russian Federation, United States

Contacts

• Name: Clinical trials department
• Affiliation: Ipsen Innovation

• Name: Clinical trials department
• Affiliation: Ipsen Innovation

Key inclusion & exclusion criteria

Inclusion criteria:
• Provision of written informed consent prior to any study related procedures.
• Subjects with hemiparesis and aged between 18 and 80 years, inclusive.
• Subjects who had one clinically defined stroke episode, as defined by the World Health Organization (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 (ie. scan or MRI).
• At least 6 months post-stroke or post traumatic brain injury.
• 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.
• Disability Assessment Scale (DAS) score =2 on the PTT.
• Spasticity angle =10° in the primary targeted muscle group.
• Modified Frenchay Scale (MFS) overall score (average of all task scores) between 1 and 8 (including limit values).

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 103

Exclusion criteria:
• Major limitation in the passive ROM at the affected elbow, wrist and fingers, as defined by:
o Maximum passive elbow extension <150° (0° corresponding to the minimal stretch of the elbow flexors, which corresponds to a fully flexed elbow position),
o Maximum passive wrist extension <70° (0° corresponding to the minimal stretch of the wrist flexors, which corresponds to a fully flexed wrist position),
o Maximum passive finger extension <70° (0° corresponding to the minimal stretch of the extrinsic finger flexors, which corresponds to a formed fist with the second phalanx parallel to the metacarpal).
• Physiotherapy initiated less than 4 weeks before entry or expected to be initiated during the study.
• Previous treatment with BTX of any type within 4 months prior to study entry for any condition.
• Subjects likely to be treated with BTX of any type in the lower limb during the course of this double blind study.
• Previous primary or secondary non response to any BTXs for the targeted condition.
• 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 adverse events (AEs) related to 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 excipient 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 (i.e. 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 traumatic brain injury) 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 or during the 4 weeks before study entry




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Arm Spasticity
MedDRA version: 14.1 Level: LLT Classification code 10048970 Term: Arm spasticity System Organ Class: 100000004852

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: DYSPORT™ for Injection
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: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Intramuscular use

Primary Outcome(s)

Main Objective: The primary study objective is to assess the efficacy of Dysport compared to placebo in reducing upper limb muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury. The primary study objective will be assessed by comparing between treatment groups at Week 4 the change from baseline in muscle tone (using the Modified Ashworth Scale (MAS)) in the primary targeted muscle group.

Primary end point(s): • Modified Ashworth Scale (MAS) for rating muscle tone in the primary targeted muscle group.

Timepoint(s) of evaluation of this end point: Week 4

Secondary Objective: The secondary study objectives include assessments of the efficacy of Dysport compared to placebo on:
• The Physician’s Global Assessment (PGA) of treatment response.
• The upper limb passive function using the Principal Target of Treatment (PTT) of the Disability Assessment Scale (DAS).

Secondary Outcome(s)

Secondary end point(s): • Mean PGA Score
• Mean change from baseline in the PTT of the DAS

Timepoint(s) of evaluation of this end point: • Mean PGA Score at Week 4.
• Mean change from baseline in the PTT of the DAS at Week 4.

Secondary ID(s)

Y-52-52120-145

2010-019069-28-CZ

Source(s) of Monetary Support

Ipsen Innovation