An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients with Severe Insomnia

NCT ID: NCT06053840

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-05-07

Brief Summary

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.

Conditions

Insomnia; Insomnia Chronic; Chloral Hydrate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Group Type: EXPERIMENTAL

Chloral Hydrate

Intervention Type: DRUG

Participants will be involved in the trial for approximately 7-8 weeks, the first week to collect baseline data and complete screening and eligibility confirmation, the following two weeks they will administer IMP, and there will be a further 4 week observation period. All trial recruitment and follow-up procedures will be conducted remotely via telephone/video calls.

Interventions

Chloral Hydrate

Participants will be involved in the trial for approximately 7-8 weeks, the first week to collect baseline data and complete screening and eligibility confirmation, the following two weeks they will administer IMP, and there will be a further 4 week observation period. All trial recruitment and follow-up procedures will be conducted remotely via telephone/video calls.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmanovia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lindus Health, The Leather Market Weston Street, Bermondsey,

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

1007757

Identifier Type: -

Identifier Source: org_study_id