EUCTR2005-004834-42-HU
进行中（未招募）
不适用
A Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Safety Study ofPulmonary Function in Patients with Reduced Lung Function Treated with BOTOX®(Botulinum Toxin Type A) Purified Neurotoxin Complex for Focal Upper LimbSpasticity Due to Upper Motor Neuron Syndrome
相关药物BOTOX
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Allergan
- 入组人数
- 150
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Male or female, 18 years of age or older
- •2\. Written informed consent
- •3\. Written Authorization for Use and Release of Health and Research Study
- •Information has been obtained.
- •4\. Medically stable subjects with stable compromised baseline respiratory
- •status who have spastic muscles in at least the upper limb that manifests as
- •common spasticity induced patterns of the upper motor neuron syndrome
- •5\. History of upper motor neuron syndrome that results in upper limb spasticity
- •of one or both upper limbs (spasticity in lower limb is allowed but will not
- •be treated with study medication)
排除标准
- •1\. Stroke within 6 months of Visit 2
- •2\. Known allergy or sensitivity to the study medication or its components
- •3\. Previous therapy with BOTOX or any other botulinum toxin for any
- •4\. Females who are pregnant, nursing, or planning a pregnancy during the
- •study, or females of childbearing potential, not using a reliable means of
- •contraception
- •5\. Subjects with multiple sclerosis or primary lateral sclerosis where
- •progression of the disease may confound study results
- •6\. Any medical condition that may put the subject at increased risk with
- •exposure to BOTOX® including diagnosed myasthenia gravis, Eaton\-
结局指标
主要结局
未指定
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