NCT06053840已完成4 期
An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients with Severe Insomnia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pharmanovia
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess the effectiveness of Chloral Hydrate in reducing insomnia severity
研究概览
简要总结
The primary aim of this Real-World Evidence trial is to establish whether short-term (2 weeks) treatment of Chloral Hydrate is effective in patients with severe insomnia which is interfering with normal daily life, and where other behavioural and pharmacologic therapies have failed in a real world setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years and ≤75 years
- •Participant is willing and able to give informed consent
- •Clinically significant impairment from severe insomnia (eg. ISI score 22-28)
- •Previous treatment with sleep therapies (behavioural and pharmacologic), which have failed. Defined as the presence of ongoing severe insomnia (ISI score 22-28), despite previous use of other sleep therapies.
- •Able to adhere to trial procedures
- •Willingness to take a pregnancy test prior to starting IMP treatment (participants of childbearing potential)
排除标准
- •Pregnant or breastfeeding
- •Taking any substances that significantly affect sleep during the 2 week IMP treatment period
- •Starting any new behavioural sleep therapies* during the 2 week IMP treatment period
- •At point of enrolment taking substances that affects sleep at greater than maximum licensed doses
- •Other sleep diagnosed/suspected sleep disorders (restless legs, periodic limb movements, unusual sleep timings (indicative of advanced/delayed sleep, etc), parasomnias
- •Known severe hepatic impairment
- •Known moderate / severe renal impairment / eGFR <60
- •Known severe sleep apnea
- •Known severe cardiac disease
- •Known cardiac disease with QT prolongation
- •History of myocardial infarction in the last 12 months
- •History of stroke or TIA
- •Taking medication that may cause QT prolongation
- •Active gastritis, oesophagitis, gastric or duodenal ulcers or perforation
- •Susceptible to acute attacks of porphyria
- •Hypersensitivity to Chloral Hydrate or to any of the excipients (glycerol, liquid glucose, citric acid, sodium citrate, sodium benzoate, saccharin sodium, essence of passion fruit [containing natural flavouring, artificial flavouring, propylene glycol], and purified water)
- •Individuals with a history of alcohol or drug abuse or dependence
- •Patients taking antipsychotic medication in last 12 months
- •History of overdose or attempted overdose
- •History of significant psychiatric disease
- •Patients are taking one of the drugs listed as interacting with Chloral Hydrate and would need to continue taking these during the trial: alcohol, CNS depressants, antipsychotics, hypnotics, anxiolytics/sedatives, antidepressant agents, centrally acting muscle relaxants, narcotic, analgesics, anti-epileptic drugs, anaesthetics and sedative antihistamines, intravenous furosemide, anticoagulants.
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- •Participants who have participated in another research trial involving an investigational product in the past 4 months
- •Participants of childbearing potential (participants who are anatomically and physiologically capable of becoming pregnant), or have a partner of childbearing potential, not willing to use highly effective contraceptives** for the duration of the trial, and who do not confirm a negative pregnancy test prior to starting the IMP.
研究组 & 干预措施
Treatment
Experimental
干预措施: Chloral Hydrate (Drug)
结局指标
主要结局
To assess the effectiveness of Chloral Hydrate in reducing insomnia severity
时间窗: Self-rated insomnia severity, assessed at baseline and 2 weeks
Change in self-rated insomnia severity, assessed using the Insomnia Severity Index
次要结局
- To explore whether Chloral Hydrate will affect Daytime sleepiness(Epworth Sleepiness Scale scores, assessed at baseline, 1 week, 2 weeks and 6 weeks)
- To investigate the safety of Chloral Hydrate(AEs and SAEs for the 6 week trial duration)
- To investigate intervention adherence(Daily intervention adherence survey questions on days 1-14)
- To determine any reductions in 1. Concomitant prescribed medication 2. Over the counter medication used to facilitate sleep(1. Concomitant medication assessed at baseline, 1 week, 2 weeks and 6 weeks 2. Over the counter medication used to facilitate sleep assessed at baseline, 1 week, 2 weeks and 6 week)
- To explore whether Chloral Hydrate will affect Self-rated insomnia severity, assessed at baseline and 2 weeks(Self-rated insomnia severity, assessed at baseline, 1 week and 6 weeks)
- To explore whether Chloral Hydrate will affect anxiety and Depression(HADS scores, assessed at baseline, 1 week, 2 weeks and 6 weeks)
- To determine any reductions in the use of non-pharmacological sleep therapies(Non-pharmacological sleep therapies assessed at baseline, 1 week, 2 weeks and 6 weeks)
- To explore whether Chloral Hydrate will affect Insomnia severity(Self-rated insomnia severity, assessed at baseline, 1 week and 6 weeks)
- To explore whether Chloral Hydrate will affect Health-related quality of life(SF-36 and EQ-5D-5L responses, assessed at baseline, 1 week, 2 weeks and 6 weeks)
- To explore whether Chloral Hydrate will affect Quality of sleep and sleep disturbances(PSQI responses assessed at baseline, 2 weeks and 6 weeks)
- To assess tolerance of Chloral Hydrate(Total number of participants withdrawn from the IMP due to an AR)
- Medical doctor assessment of effectiveness of Chloral Hydrate(CGI-S assessed at baseline, and CGI-I assessed at 2 weeks and 6 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Atrial Fibrillation Feasibility Certoparin Trial - AFFECTPersistent Nonvalvular Atrial FibrillationNCT00171769Novartis200
撤回
2 期
A Study to Assess Efficacy and Safety of Oral Tazemetostat in Adult Participants With Relapsed/Refractory Follicular Lymphoma That Does Not Have an "EZH2 Gain-of-function" Genetic MutationRefractory Follicular LymphomaFollicular LymphomaNCT06068881Epizyme, Inc.55
终止
4 期
Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)Hepatitis C, ChronicNCT01606800Merck Sharp & Dohme LLC45
已完成
2 期
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.Non Small Cell Lung CancerNCT00160043Bayer112
已完成
1 期
Alzheimer's Disease Stem Cells Multiple InfusionsAlzheimer DiseaseNCT04040348Bernard (Barry) Baumel6