CTIS2022-502483-21-00招募中1 期
Efficacy and tolerability of tasipimidine after 3 repeated bed-time doses in patients with insomnia disorder - 3110012
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 144
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Signed informed consent (IC) for participation in the study., Male or female subjects with age between 18 and 65 years (inclusive) at screening visit., Insomnia disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition Text Revision (DSM-5-TR®)., 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., Insomnia Severity Index© (ISI©) score = 15., Usual bedtime between 21:00 and 02:00., Regular time in bed between 6 and 9 hours., 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., Female subjects with fertile male partner, and male subjects with female partners of child-bearing 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 last menstrual cycle) are considered not to be reproductive and can be included.
排除标准
- •A predictable poor compliance or inability to understand and comply with protocol requirements, instructions and protocol-stated restrictions, or communicate well with the investigator., Start of other new chronic medication within 14 days or 5 times the half-life, whichever is longer, prior to the 1st screening PSG., 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., Any lifetime history of a diagnosed sleep-related breathing disorder, including chronic obstructive pulmonary disease and sleep apnoea., 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., 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 screening visit., 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., Myocardial infarction or other clinically significant ischemic cardiac disease, heart failure, sick-sinus syndrome or arrhythmia tendency within the past 2 years., History of clinically significant orthostatic hypotension, syncope or syncopial attacks within the past 2 years., 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 subject if he/she takes part in the study., Heavy tobacco use (at least one pack of cigarettes a day or corresponding heavy use of other nicotine containing products or inability to refrain from smoking during the night)., Body mass index below 18.5 or above 40.0 kg/m2., Caffeine consumption = 600 mg per day or regular caffeine consumption after 4 p.m., Supine HR < 50 bpm or > 100 bpm after a 5-minute rest at screening visit., Systolic blood pressure (SBP) < 100 or > 160 mmHg or diastolic blood pressure (DBP) < 50 or > 100 mmHg after a 5-minute rest at screening visit., Orthostatic hypotension (decrease of = 20 mmHg for SBP or decrease of = 10 mmHg for DBP) or dizziness in orthostatic test at screening visit., Abnormal 12-lead ECG finding of clinical relevance at the screening visit, (after 5 min rest in supine position, confirmed by a repeat measurement) for example:• QTc (calculated through the Fridericia’s formula) repeatedly > 450 ms in males or > 470 ms in females at screening visit. Pacemaker rhythm as such does not need to lead to exclusion. (If QTc interval measured by the ECG machine algorithm is > 450 ms, 2 additional recordings will be done and QTcF values confirmed) •2° or 3° AV block., AST and/or ALT > 2 × ULN and/or direct bilirubin > 1.5 × ULN., Positive urine drug screen or presence of alcohol in exhaled breath at screening visit, screening PSG nights or o
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