NCT00401284已完成2 期
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Hypnotic Efficacy of EVT 201 in Elderly Patient With Daytime Sleepiness
Evotec Neurosciences GmbH42 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2006年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 42
- 主要终点
- Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7
研究概览
简要总结
The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating elderly patients diagnosed with primary insomnia who also have moderate daytime sleepiness.
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
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary insomnia according to DSM-IV
- •Over the last three months for at least 5 nights per week, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours
- •A history of sleepiness, tiredness or unintentional napping during the daytime attributed to to poor sleep at night
- •Able to attend the Sleep Center for five nights (two consecutive nights on two occasions and one night on one occasion)over a five week period
- •Willing and able to complete a sleep diary and questionnaires
排除标准
- •Clinically significant or unstable medical condition that may interfere with sleep
- •Major psychiatric disorders (other than insomnia) such as depression, schizophrenia, bipolar disorder
- •History of myocardial infarction, cardiac failure or clinically significant dysrhythmias in the previous 2 years or clinically significant ECG abnormalities at screening
- •History of substance abuse
- •Disorders that interfere with drug pharmacokinetics
- •History of cancer, except basal cell carcinoma
- •Use of hypnotics, anxiolytics, antidepressants, anticonvulsants, over-the-counter sleep aids, histamine-1 receptor antagonists (except for loratadine and fexofenadine), beta-adrenergic blockers (except for atenolol), respiratory stimulants and decongestants, systemic steroids, narcotic analgesics, any other compound which might impact sleep-wake function, or medication used for the treatment of Parkinson's disease such as dopamine agonists and L-dopa (e.g., Sinemet, Madopar or Requip)
- •Use of hypnotics within the 2 weeks preceding the Screening Period or within five half-lives of the medication, whichever is longer
- •Consuming ≥ 350 mg per day of xanthine-containing food or beverages
- •Smoking ≥ 10 cigarettes per day and/or unable to refrain from smoking without distress or discomfort for the duration of visits to the sleep laboratory (i.e.≥ 20 hours)
- •Body mass index > 34 kg/m2;
- •Performing night work or rotating shift work during the past month
- •Traveling across > 3 time zones in the past 2 weeks
- •Participation in another trial of an investigational product or device within the previous 30 days
- •Known allergy or sensitivity to benzodiazepines
结局指标
主要结局
Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7
次要结局
- Mean Multiple Sleep Latency Test at Day 8
- Mean Psychomotor Vigilance Task at Day 8
- Mean Karolinska Sleepiness Scale at Day 8
- Mean Rey Auditory Verbal Learning Test at Day 8
- Mean Profile of Mood State at Day 8
- Polysomnography derived variables averaged over nights 1, 6 and 7
- Patient reported evaluations of sleep quality and quantity over nights 1 to 7
- Benzodiazepine withdrawal questionnaire at baseline and follow-up
- Safety including adverse events, ECGs, vital signs, routine laboratory tests throughout the study
研究者
研究点 (42)
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