NCT00773591撤回2 期
Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-related Breathing Disorders (Snoring Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Comparison of the ratio of snoring time over sleeping time (Snoring Index)
研究概览
简要总结
This proof-of-concept study is to assess the potential benefit of botulinum toxin for patients with sleep-related breathing disorders.
详细描述
Mono-center, double-blind, 1:1 randomized, placebo-controlled trial 18 treated patients, 9 patients per group.
Patients will be randomly assigned to treatment with NT 201 or placebo in a ratio of 1:1. In addition, within each treatment group patients will be randomly assigned to injection into the left or right soft palate.
Primary variable:
Comparison of the ratio of snoring time over sleeping time (Snoring Index). Other secondary variables will be analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients of at least 18 years of age.
- •Patient who understand the nature of the study and provide written informed consent prior to protocol-specific procedures.
- •Patients suffering from sleep-related breathing disorders for at least 3 months prior to study start and seeking help for their snoring.
- •Non-REM RDI ≤ 25/h (according to Medicare Criteria) at baseline PSG.
- •AHI ≤ 10/h at baseline PSG.
- •Snoring Index ≥ 15 at baseline PSG.
排除标准
- •Patients with known hypersensitivity to:
- •botulinum neurotoxin type;
- •any of the excipients (human albumin, sucrose).
- •Patients with upper respiratory tract pathology as assessed by an ear, nose, and throat [ENT] specialist.
- •Patients with generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome).
- •Patients with bleeding disorders of any type and/or receiving anticoagulant therapy.
- •Patients with a profound sleep disorder (pathological number and duration of episodes of hypopnea and apnea), upper airway resistance syndrome [UARS], or obstructive sleep apnea syndrome [OSAS].
- •Obese patients (BMI ≥ 30).
- •Presence of concomitant diseases:
- •severe or unstable cardiovascular (e.g. severe angina pectoris, post myocardial infarction and ventricular extra systoles), pulmonary, or endocrine disease; clinically relevant renal or hepatic disease or dysfunction; hematological disorder; any other clinically relevant medical condition that could increase the risk to the study participant;
- •malignant disease of any kind during the previous 5 years except for successfully treated skin (basal or squamous cell) cancer;
- •amyotrophic lateral sclerosis or other diseases which result in peripheral neuromuscular dysfunction;
- •risk of developing an angle closure glaucoma;
- •alcohol, drug, or medication abuse within the past year;
- •severe psychiatric or neurological disorders;
- •acute infections of the pharynx.
- •Patients likely to need concomitant medication as follows:
- •4-aminochinolines;
- •aminoglycosides or spectinomycin, or other medical products interfering with neuromuscular transmission, e.g. tubocurarine-type muscle relaxants;
- •daily psychotropic medication;
- •regular intake or onset of hypnotics, e.g. benzodiazepines, chloralhydrate and combinations, barbiturates (except of mild phytotherapeutics, e.g. valerian, hop and combinations);
- •anti-snoring products during the course of the study such as foams, dental devices.
- •Pregnant or nursing women, or women of childbearing potential who are not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/ hysterectomized.
- •Participation in a clinical study within the last 30 days prior to the start of the study.
- •Patients who are employees, relative or spouse of the investigator, of other staff of the investigational site or the sponsor or the CRO.
- •Any donation of germ cells, blood, organs, or bone marrow during the course of the study.
- •Patients who are expected to be non-compliant and/or not cooperative.
- •Patients who are not contractually capable.
研究组 & 干预措施
Botulinum Toxin Typ A
Active Comparator
干预措施: NT 201, a Botulinum neurotoxin type A, free of complexing proteins (Drug)
Placebo
Placebo Comparator
干预措施: NT 201, a Botulinum neurotoxin type A, free of complexing proteins (Drug)
结局指标
主要结局
Comparison of the ratio of snoring time over sleeping time (Snoring Index)
时间窗: Snoring Index measured from baseline to follow-up visit and to V3.
次要结局
- Change in ventilation (oral/nasal flow) from V0 to V2 and from V0 to V3 including: → Peakflow Vmax → Tidal volume (Vt)(Change in several Secondary variables from baseline over time)
研究者
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