EUCTR2011-005375-16-DK进行中（未招募）1 期
A PHASE III PROSPECTIVE, MULTI-CENTER, RANDOMISED, EVALUATOR-BLINDED STUDY TO COMPARE NEUROMUSCULAR JUNCTION (NMJ) TARGETED TECHNIQUE FOR DYSPORT INJECTIONS IN UPPER LIMB SPASTICITY POST STROKE OR TRAUMATIC BRAIN INJURY TO THE TECHNIQUE USED IN CURRENT CLINICAL PRACTICE - The NMJ Study
Institut Produits Synthèse (IPSEN) AB0 个研究点目标入组 100 人开始时间: 2012年2月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •o Provision of written informed consent prior to any study related procedures,
- •o Subjects male or female, aged 18 or older,
- •o Upper limb spasticity post stroke or traumatic brain injury,
- •o Spasticity position pattern type 1, 3 or 4,
- •o Elbow flexor muscles spasticity MAS 2 to 3,
- •o At least 2 consecutive previous treatment cycles of BoNT-A for current diagnosis,
- •o The latest treatment cycle demonstrating good treatment efficacy where the Dysport dose administered was considered to be adequate according to Investigator judgement,
- •oNeed of the same treatment modality in m. brachialis, m. biceps brachii, m. brachioradialis, m. flex. carpi ulnaris, m. flex. carpi radialis as the previous treatment cycle,
- •o Last BoNT-A treatment 12-24 weeks ago
- •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 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Subjects will not be included in the study if they meet any or the following criteria:
- •Poor response to BoNT-A treatment, according to Investigator,
- •Need of Dysport doses >800U in the upper limb,
- •Concomitant treatment with BoNT-A for other indications than spasticity,
- •Any elbow flexor contracture prohibiting MAS evaluation and/or elbow flexion improvement of at least 1 step on the MAS
- •Cutaneous or joint inflammation in the affected upper limb,
- •Is likely to start other spasticity treatment during the study,
- •Is likely to start physiotherapy treatment during the study,
- •Other ongoing neurological disorder (e.g., myasthenia gravis),
- •History of dysphagia or aspiration,
- •Use of agents interfering with neuromuscular transmission (e.g., aminoglycosides),
- •Treated with an investigational medicinal product within 30 days before start of the study,
- •Known sensitivity to BoNT-A or any components of Dysport,
- •Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test (U-hCG) at visit 1 and must be using adequate contraception. Non childbearing potential is defined as post-menopause for at least one year, surgical sterilisation or hysterectomy at least three months before the start of the study,
- •Has a history of, or known current, problems with alcohol or drug abuse,
- •Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude,
- •Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
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