EUCTR2004-003939-32-GB进行中（未招募）1 期
A double-blind placebo controlled cross-over study to determine if 1.5 and 3mg of APL510 can normalise sleep patterns in elderly subjects with difficulty in maintenance of sleep and/or initiating sleep onset. - N/A
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
入选标准
- •1.Male or female subjects aged 65 years or more presenting with self-reported poor sleep quality defined as at least two of the following:
- •a) Regularly takes more than 45 minutes to fall asleep.
- •b) Overall night time sleep less than 5 hours on at least 3 nights per week.
- •c) Regular night time awakenings defined as at least twice per night on at least 3 nights per week.
- •2.Subjects with a poor sleep quality for at least 8 weeks.
- •3.Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •1.Have a clinically significant unstable medical abnormality, chronic disease or history or presence of significant neurological, hepatic, renal, endocrine, cardiovascular, GI, pulmonary, psychiatric, metabolic disease or malignancy which in the opinion of the investigator would preclude successful participation in the study.
- •2.Have a recent history of (< 2 years) alcohol or drug abuse or current evidence of substance dependence or abuse as defined by DSM-IV criteria.
- •3.Have major depression or anxiety causing sleep disturbance as defined by DSM-IV criteria.
- •4.Had a clinically significant illness within the last 30 days.
- •5.Routine biochemistry parameters (e.g creatinine or LFTs) not greater than 2 x the ULN for this age of population. Haemoglobin less than 10
- •6.Subjects receiving B6 or B12 supplements (multivitamin supplements are allowable provided intake does not exceed the recommended daily dose).
- •7.Subjects planning to travel through more than 2 time zones whilst entered into the study.
- •8.Subjects with a known hypersensitivity to melatonin or any of the excipients in the formulation.
- •9.Subjects who, by virtue of the need to care for a close family member, are subjected to intermittent night-time disturbance.
- •10.Subjects who have experienced the bereavement of a close family member within the last 3 months.
- •11.Subjects who have used any other investigational drug within the last 30 days.
- •12.Subjects planning to work night shifts.
- •13.Subjects on treatment with anxiolytics, antidepressants, anticonvulsants, hypnotics or strong narcotic analgesics within the last 30 days. Other narcotic analgesics are allowed if they have ben used at a constant dose for at least the last 30 days, the dose is unlikely to change during the duration of the study and in the opinion of the investigator, not likely to interfere with the subject’s sleep quality. Subjects receiving hypnotics are eligible for the study if they consent to withdraw from treatment for 30 days prior to screening
- •14.Subjects with a known severe allergic or auto-immune disease.
- •15.Subjects with other conditions that may cause night time awakenings (e.g. nocturia or pain) that in the investigator’s opinion would interfere with the assessment of the subject’s sleep disturbance.
- •16. Subjects who, in the opinion of the investigator, are unlikely to complete the study satisfactorily.
研究者
相似试验
进行中（未招募）
1 期
A double-blind placebo-controlled cross-over study to determine if melatonin can improve the length of day time sleep in subjects with transient misalignment of the sleep-wake cycle as a result of working permanent night shifts.Transient misalignment of the sleep-wake cycle as a result of working night shifts (insomnia in night shift workers)EUCTR2005-000120-17-GBAlliance Pharmaceuticals Ltd60
已完成
2 期
The use of APL510 to improve the length of day time sleep in subjects working permanent night-shiftsMental and Behavioural DisordersNonorganic sleep disordersInsomniaISRCTN15733268Alliance Pharmaceuticals Ltd (UK)44
已完成
2 期
1.5 versus 3.0 mg APL510 to normalise sleep patterns in elderly subjects with insomniaMental and Behavioural DisordersNonorganic sleep disordersInsomniaISRCTN82088636Alliance Pharmaceuticals Ltd (UK)80
进行中（未招募）
不适用
A double blind placebo controlled crossover study to determine the effects of atomoxetine on event-related potentials in response to auditory oddball stimuli during an on-the-road driving test in adult patients with attention deficit hyperactivity disorder - Effects of atomoxetine on attention and driving in adult ADHDThe effects of atomoxetine on driving performance, attention and response inbihition are studied in adult patients with attention-deficit hyperactivity disorderEUCTR2007-001855-20-NLFaculty of Social Sciences, Utrecht University30
撤回
不适用
A double blind placebo-controlled crossover study to determine the effects of atomoxetine on event-related potentials in response to auditory oddball stimuli during an on-the-road driving test in adult patients with attention-deficit hyperactivity disorderADHD10009841Attention Deficit Hyperactivity DisorderNL-OMON31557niversiteit Utrecht30