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

Pharmanovia1 site in 1 country100 target enrollmentSeptember 1, 2023

ConditionsInsomnia Insomnia Chronic Chloral Hydrate

InterventionsChloral Hydrate

DrugsChloral Hydrate

Overview

Phase: Phase 4
Intervention: Chloral Hydrate
Conditions: Insomnia
Sponsor: Pharmanovia
Enrollment: 100
Locations: 1
Primary Endpoint: To assess the effectiveness of Chloral Hydrate in reducing insomnia severity
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2023

End Date

May 7, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pharmanovia

Responsible Party

Sponsor

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

Arms & Interventions

Treatment

Intervention: Chloral Hydrate

Outcomes

Primary Outcomes

To assess the effectiveness of Chloral Hydrate in reducing insomnia severity

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

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

Secondary Outcomes

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)