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

NCT06053840 | Completed Phase 4

• 1 other identifier: 1007757
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To assess the effectiveness of Chloral Hydrate in reducing insomnia severity

  Change in self-rated insomnia severity, assessed using the Insomnia Severity Index

  Self-rated insomnia severity, assessed at baseline and 2 weeks

Secondary Outcomes (12)

• 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 Daytime sleepiness

  Epworth Sleepiness Scale scores, 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 anxiety and Depression

  HADS scores, assessed at baseline, 1 week, 2 weeks and 6 weeks

Other Outcomes (1)

• To assess days off work

  Percentage of days off work one month and 12 months prior to baseline, and assessed at 2 weeks (for the 2 week treatment period) and 6 weeks (for the 4 week observation period)

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: Chloral Hydrate

Interventions

Chloral Hydrate 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.

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmanovia: lead

Study Sites (1)

Lindus Health, The Leather Market Weston Street, Bermondsey,

London, SE1 3ER, United Kingdom

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Chloral Hydrate

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: September 26, 2023
• Study Start: September 1, 2023
• Primary Completion: April 24, 2024
• Study Completion: May 7, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)