ISRCTN10433315已完成4 期
An open-label tRial to Evaluate the SafeTy and efficacy Of chloral hydrate in patients with seveRE insomnia (RESTORE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pharmanovia
- 入组人数
- 99
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. Aged =18 years and =75 years
- •2. Participant is willing and able to give informed consent
- •3. Clinically significant impairment from severe insomnia (eg. ISI score 22-28)
- •4. 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.
- •5. Able to adhere to study procedures
- •6. Willingness to take a pregnancy test prior to starting IMP treatment (participants of childbearing potential)
排除标准
- •1. Pregnant or breastfeeding
- •2. Taking any substances that significantly affect sleep during the 2 week IMP treatment period
- •3. Starting any new behavioural sleep therapies* during the 2 week IMP treatment period
- •4. At point of enrolment taking substances that affects sleep at greater than maximum licensed doses
- •5. Other sleep diagnosed/suspected sleep disorders (restless legs, periodic limb movements, unusual sleep timings (indicative of advanced/delayed sleep, etc), parasomnias
- •6. Known severe hepatic impairment
- •7. Known moderate / severe renal impairment / eGFR <60
- •8. Known severe sleep apnea
- •9. Known severe cardiac disease
- •10. Known cardiac disease with QT prolongation
- •11. History of myocardial infarction in the last 12 months
- •12. History of stroke or TIA
- •13. Taking medication that may cause QT prolongation
- •14. Active gastritis, oesophagitis, gastric or duodenal ulcers or perforation
- •15. Susceptible to acute attacks of porphyria
- •16. 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)
- •17. Individuals with a history of alcohol or drug abuse or dependence
- •18. Patients taking antipsychotic medication in last 12 months
- •19. History of overdose or attempted overdose
- •20. History of significant psychiatric disease
- •21. 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.
- •22. 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.
- •23. Participants who have participated in another research trial involving an investigational product in the past 4 months
- •24. 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 drug.
- •*Participants currently undergoing behavioural sleep therapies, such as CBT, will continue on these during the trial, in line with the licensing for chloral hydrate licensing, where chloral hydrate should be used as an adjunct to behavioural therapies. However, they should not start any new behavioural sleep therapies during the 2 week IMP treatment period.
- •**Highly effective methods have typical-use failure rates of less than 1% and include sterilisation and long-acting reversible contraceptive (LARC) methods (intrauterine devices and implants) OR if a couple are using another method of contraception, such as a combined hormonal method, progestogen only pill or injection, they are only eligible if they are willing to use an additional barrier method (e.g. male condom) for the 28-day duration of follow-up in the trial. Note: a barrier method on its own is not sufficient.
研究者
相似试验
进行中（未招募）
1 期
A trial to evaluate the safety, tolerability and efficacy of long-term lacosamide use as adjunctive therapy in children with epilepsy.MedDRA version: 16.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersEpilepsyEUCTR2011-001559-35-ITCB BIOSCIENCES, Inc192
进行中（未招募）
1 期
A trial to evaluate the safety, tolerability and efficacy of long-term lacosamide use as adjunctive therapy in children with epilepsy.MedDRA version: 21.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersEpilepsyEUCTR2011-001559-35-HUCB BIOSCIENCES, Inc400
进行中（未招募）
1 期
An Open-Label Study to Determine Safety , Tolerability, andEfficacy of Oral Lacosamide in Children with EpilepsyMedDRA version: 20.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersEpilepsyEUCTR2011-001559-35-DECB BIOSCIENCES, Inc354
进行中（未招募）
1 期
A trial to evaluate the safety, tolerability and efficacy of long-term lacosamide use as adjunctive therapy in children with epilepsy.EpilepsyMedDRA version: 21.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersEUCTR2011-001559-35-PLCB BIOSCIENCES, Inc400
进行中（未招募）
1 期
An Open-Label Study to Determine Safety, Tolerability, and Efficacy of Oral Lacosamide in Children with EpilepsyMedDRA version: 21.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersEpilepsyEUCTR2011-001559-35-Outside-EU/EEACB BIOSCIENCES, Inc