EUCTR2011-001779-38-DE进行中（未招募）不适用
Prospective, randomized, double-blind, placebo-controlled, parallel-group, 3-stage dose-finding study to identify a safe and effective dose of NT 201 for unilateral injection into the soft palate for treatment of habitual snoring - Snoring
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
- 48
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
- •-Female or male subjects aged 18-70
- •-Subjects suffering from snoring for at least 3 months prior to the study start and seeking for help to treat snoring
- •-Subjects with a peak Snoring Index [SI] = 15/ hour of sleep [h] at baseline visit V2
- •-Subjects with a bed partner for at least the last three months prior to study start
- •-Subjects who understand the nature of the study and provide written Informed Consent [IC] at screening visit V1.
- •-Subjects who understand the study procedures as well as possess the ability and willingness to abide by all procedures during the course of the study
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
- •-Female or male subjects aged 18-70
- •-Subjects suffering from snoring for at least 3 months prior to the study start and seeking for help to treat snoring
- •-Subjects with a peak Snoring Index [SI] = 15/ hour of sleep [h] at baseline visit V2
- •-Subjects with a bed partner for at least the last three months prior to study start
- •-Subjects who understand the nature of the study and provide written Informed Consent [IC] at screening visit V1.
- •-Subjects who understand the study procedures as well as possess the ability and willingness to abide by all procedures during the course of the study
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Obese subjects (Body Mass Index = 30)
- •-Subjects with severe obstructive sleep apnea syndrome [OSAS]
- •-Subjects with Apnea-Hypopnea Index [AHI] = 10 /hour of sleep and/ or Respiratory Disturbance Index [RDI] = 25 / hour of sleep at the baseline visit V2
- •-Subjects who have undergone any Botulinum neurotoxin treatment in the history
- •-Subjects with generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome)
- •-Acute infections of the pharynx
- •-Obese subjects (Body Mass Index = 30)
- •-Subjects with severe obstructive sleep apnea syndrome [OSAS]
- •-Subjects with Apnea-Hypopnea Index [AHI] = 10 /hour of sleep and/ or Respiratory Disturbance Index [RDI] = 25 / hour of sleep at the baseline visit V2
- •-Subjects who have undergone any Botulinum neurotoxin treatment in the history
- •-Subjects with generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome)
- •-Acute infections of the pharynx
研究者
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