ISRCTN35042256进行中（未招募）2 期
Efficacy and tolerability of tasipimidine after 3 repeated bed-time doses in patients with insomnia disorder
Orion Corporation (Finland)0 个研究点目标入组 96 人开始时间: 2023年8月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent (IC) for participation in the study
- •2. Male or female subjects aged between 18 and 65 years (inclusive) at the screening visit
- •3. Insomnia disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition Text Revision (DSM-5-TR®)
- •4. Self-reported history of the following on at least 3 nights per week and for at least 3 months prior to the screening: = 30 minutes to fall asleep, subjective total sleep time (sTST) = 6 hours.
- •5. Insomnia Severity Index© (ISI©) score = 15
- •6. Usual bedtime between 21:00 and 02:00
- •7. Regular time in bed between 6 and 9 hours
- •8. Meeting the following sleep parameter criteria on the 2 screening PSG nights: mean latency to persistent sleep (LPS) = 25 minutes (with none of the 2 nights < 15 minutes) and mean total sleep time (TST) = 6 h
- •9. Female subjects with fertile male partners, and male subjects with female partners of childbearing potential, must adhere to a highly effective form of contraception, if sexually active and not permanently sterilised. Additionally, women who are postmenopausal (1 year since the last menstrual cycle) are considered not to be reproductive and can be included.
排除标准
- •1. A predictable poor compliance or inability to understand and comply with protocol requirements, instructions and protocol-stated restrictions, or communicate well with the investigator
- •2. Body mass index below 18.5 or above 40.0 kg/m2
- •3. Self-reported usual daytime napping = 1 hour per day, and = 3 days per week
- •4. Shift work within 2 weeks prior to the screening visit, or planned shift work during the study
- •5. Travel across = 3 time zones within 2 weeks prior to the screening visit, or planned travel across = 3 time zones during the study
- •6. Use of medications with known relevant alpha-2 AR affinity (e.g. mirtazapine, mianserine, dexmedetomidine, clonidine, guanfacine or tizanidine) or known strong or moderate CYP2D6 inhibitors (e.g. paroxetine, fluoxetine, bupropion, quinidine) within 14 days or 5 times the half-life, whichever is longer, prior to the 1st screening PSG
- •7. Use of benzodiazepines, z-drugs (zolpidem, zopiclone, eszopiclone, zaleplon), melatonin, sedative H1 antagonists, sedative antidepressants (e.g. doxepine and trazodone), orexin receptor antagonists (e.g. daridorexant) or antipsychotics within 14 days or 5 times the halflife, whichever is longer, prior to 1st screening PSGs
- •8. Use of amphetamine derivatives like methylphenidate, dexamphetamine and lisamphetamine within 14 days, or 5 times the half-life, whichever is longer, prior to the 1st screening PSG
- •9. Use of other CNS-active drugs, including over-the-counter or herbal medicines, for 14 days or 5 times the half-life, whichever is longer, prior to the 1st screening PSG
- •10. Start other new chronic medication within 14 days or 5 times the half-life, whichever is longer, prior to the 1st screening PSG
- •11. Cognitive behavioural therapy (CBT) for any indication is allowed only if the CBT started at least 1 month prior to the 1st screening PSG and the subject agreed to continue the CBT throughout the study
- •12. Any lifetime history of sleep-related breathing disorders, including chronic obstructive pulmonary disease and sleep apnoea
- •13. Acute or unstable psychiatric conditions as judged by the investigator (including but not restricted to current bipolar disorder, schizophrenia or obsessive-compulsive disorder) that are diagnosed by the Mini International Neuropsychiatric Interview© (MINI©) or that require pharmacological treatment for these disorders. N.B.: subjects with a history of major depressive disorder or anxiety disorder that are currently stable, and without requiring pharmacological treatment are eligible
- •14. Positive answer to item 4 or 5 on the Colombia-Suicide Severity Rating Scale (C-SSRS) or current risk of suicide based on the investigator’s judgement at the screening visit
- •15. Diagnosis of alcohol or substance use disorder within 2 years prior to the screening visit or inability to refrain from drinking alcohol for at least 3 consecutive days.
- •16. Myocardial infarction or other clinically significant ischemic cardiac disease, heart failure, sick sinus syndrome or arrhythmia tendency within the past 2 years
- •17. History of clinically significant orthostatic hypotension, syncope or syncopial attacks within the past 2 years
- •18. Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological (e.g. epilepsy or dementia) or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator may interfere with the interpretation of the study results or constitute a health risk for the
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