EUCTR2012-005539-10-DE进行中（未招募）1 期
Prospective, randomized, double-blind, placebo-controlled, parallel-group multicenter study, with an extension period of dose-blinded active treatment, to investigate the efficacy and safety of two dose levels of NT 201 in treating chronic troublesome sialorrhea in various neurological conditions - SIAXI – Sialorrhea in Adults Xeomin Investigation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- •Documented diagnosis of the basic neurological condition associated with sialorrhea (with onset at least 6 months before screening); Chronic troublesome sialorrhea related to parkinsonism or stroke or traumatic brain injury (for at least 3 months) at screening, defined as the presence of all of the following, at screening and at baseline and for at least the 3 months before screening ; A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points and a score of at least 2 points for each item of the DSFS and a score of at least 3 points on the modified Radboud Oral Motor Inventory for Parkinson’s Disease [mROMP], Section ‘III Drooling’, Item A); A score of at most 2 points on the mROMP Section ‘II Swallowing Symptoms’ Item A) and a score of at most 3 points on Item C), at screening and at baseline.
- •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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 153
排除标准
- •Non-neurological secondary causes of sialorrhea; Unstable concomitant medication influencing sialorrhea (such as anticholinergics for the treatment of parkinsonism; dosages of these medications must have been stable for at least 4 weeks before study entry , i.e. Screening, and must be planned to remain stable during the course of the study; Recent (i.e., four weeks) drug treatment for sialorrhea; History of recurrent aspiration pneumonia; Extremely poor dental/oral condition as assessed by a qualified dentist; Recent (i.e., one year for sialorrhea, 14 weeks for other indications) treatment with – or known hypersensitivity to – Botulinum toxin, or known hypersensitivity to any ingredient of the study preparation; Recent (i.e., four weeks) changes in anti-parkinsonian medication; Previous or planned surgery or irradiation to control sialorrhea.
研究者
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