A Phase III, Multicenter, Double Blind, Randomised, Placebo Controlled Study to Assess the Efficacy and the Safety of a Single Cycle of Dysport Solution in the Treatment of Upper Limb Spasticity in Adult Subjects with Spastic Hemiparesis due to Stroke. -
- Conditions
- upper limb spastic hemiparesis due to strokeMedDRA version: 20.0Level: LLTClassification code 10058978Term: Spastic hemiparesisSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2015-000554-38-IT
- Lead Sponsor
- IPSEN INNOVATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 99999
1.Provision of written informed consent prior to any study related procedures.
2.Male or female subjects between 18 and 80 years of age, inclusive.
3.Subjects with spastic hemiparesis, who had only one clinically defined stroke episode.
4.Subjects who are at least 6 months post-stroke.
5.Subjects who have a MAS score =2 in the primary targeted muscle group (PTMG) for toxin-naive subjects (never received any
Botulinum toxin [BTX] in the affected upper limb) or =3 in the PTMG for toxin nonnaive
subjects.
6.Spasticity angle (X of the Tardieu scale) =10° in the PTMG
7.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 and for 90 days after
participation in the study. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine
device, or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
8.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: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1.Major limitation in the passive ROM (XV1 of the Tardieu scale) at the affected elbow, wrist, and fingers, as defined by:
•Maximum passive elbow extension <150° (0° corresponding to the
minimal stretch of the elbow flexors, which corresponds to a fully flexed
elbow position)
•Maximum passive wrist extension <70° (0° corresponding to the
minimal stretch of the wrist flexors, which corresponds to a fully flexed
wrist position)
•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)
2.Subjects treated with BTX of any type within four months prior to study entry for any condition.
3.Subjects who have experienced remote spread of effect of previous treatment with BTX (including generalized muscle
weakness).
4.Subjects likely to be treated with BTX of any type during the course of this study.
5.Previous primary or secondary non-response to any BTXs for the targeted condition.
6.Previous surgery to treat spasticity of the affected upper limb.
7.Previous treatment with phenol and/or alcohol in the affected upper limb at any time before the study.
8.Subjects treated or likely to be treated with intrathecal baclofen during the course of the study or during the 4 weeks before
study entry.
9.Physiotherapy initiated less than 4 weeks before entry or expected to be initiated during the study in the affected upper limb.
10.Any medical condition (including severe dysphagia or airway disease) that may increase, in the opinion of the Investigator, the
likelihood of Adverse Events related to BTX treatment.
11.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.
12.Known disease of the neuromuscular junction (such as Lambert Eaton myasthenic syndrome or myasthenia gravis).
13.Known sensitivity to BTX or any component of Dysport Solution.
14.Infection at the injection site(s).
15.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.
16.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.
17.Any underlying disease (not associated with the stroke) likely to affect upper limb function and/or muscle tone and/or
spasticity.
18.Is pregnant or lactating. 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).
19.Has a history of, or known current, problems with substance or alcohol abuse.
20.Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the
study, and/or evidence of an uncooperative attitude.
21.Has any other medical condition(s) that, in the opinion of the investigator, might jeopardise the subject's safety.
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