EUCTR2010-019069-28-PL进行中（未招募）不适用
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.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 228
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Provision of written informed consent prior to any study related procedures.
- •Subjects with hemiparesis and aged between 18 and 80 years of age, inclusive.
- •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
- •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 (measured on the TS) =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:
- •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
排除标准
- •Major limitation in the passive ROM at the affected elbow, wrist and fingers, as defined by:
- •oMaximum passive elbow extension <150° (0° corresponding to the minimal stretch of the elbow flexors, which corresponds to a fully flexed elbow position),
- •oMaximum passive wrist extension <70° (0° corresponding to the minimal stretch of the wrist flexors, which corresponds to a fully flexed wrist position),
- •oMaximum 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
研究者
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