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An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia (RESTORE)

Primary Purpose

Insomnia, Insomnia Chronic, Chloral Hydrate

Status
Recruiting
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Chloral Hydrate
Sponsored by
Pharmanovia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lindus Health, The Leather Market Weston Street, Bermondsey,Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

To assess the effectiveness of Chloral Hydrate in reducing insomnia severity
Change in self-rated insomnia severity, assessed using the Insomnia Severity Index

Secondary Outcome Measures

To explore whether Chloral Hydrate will affect Self-rated insomnia severity, assessed at baseline and 2 weeks
Change in self-rated insomnia severity, assessed using the Insomnia Severity Index (ISI)
To explore whether Chloral Hydrate will affect Daytime sleepiness
Change in Epworth Sleepiness Scale scores which is based on a 0-3 scale with 0 being No chance of dozing, and 3 High chance of dozing.
To explore whether Chloral Hydrate will affect Insomnia severity
Change in self-rated insomnia severity, assessed using the Insomnia Severity Index (ISI)
To explore whether Chloral Hydrate will affect Health-related quality of life
Change in health-related quality of life, measured using the ShortForm 36 (SF-36) and EQ-5D-5L questionnaires. The SF-36 is based on a 1-5 with 1 being excellent and 5 poor. EQ-5D-5L is scored on a 0-100 scale with 0being the worst health possible, and 100 the best health you can imagine.
To explore whether Chloral Hydrate will affect anxiety and Depression
Change in Hospital Anxiety and Depression Scale (HADS) scores. The scale is based on a 0-21 scale with 0-7 = Normal, 8-10 = Borderline abnormal (borderline case), 11-21 = Abnormal (case)
To explore whether Chloral Hydrate will affect Quality of sleep and sleep disturbances
Change in Pittsburgh Sleep Quality Index (PSQI) scores
To investigate the safety of Chloral Hydrate
Evaluation of overall safety of Chloral Hydrate by the monitoring of AEs and SAEs
To investigate intervention adherence
Daily intervention adherence for the duration of the intervention (2 weeks)
To assess tolerance of Chloral Hydrate
Number of participants withdrawn from the IMP due to an AR, during the 2 week treatment period
To determine any reductions in the use of non-pharmacological sleep therapies
Change in use of non-pharmacological sleep therapies
To determine any reductions in 1. Concomitant prescribed medication 2. Over the counter medication used to facilitate sleep
Change in Concomitant medication Over the counter medication used to facilitate sleep
Medical doctor assessment of effectiveness of Chloral Hydrate
Clinical Global Impressions - Severity Scale (CGI-S) assessed at baseline, and Clinical Global Impressions - Improvement scale (CGI-I) assessed after IMP treatment by the medically qualified doctor. Rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.

Full Information

First Posted
June 21, 2023
Last Updated
October 16, 2023
Sponsor
Pharmanovia
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1. Study Identification

Unique Protocol Identification Number
NCT06053840
Brief Title
An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia
Acronym
RESTORE
Official Title
An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmanovia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Insomnia Chronic, Chloral Hydrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Chloral Hydrate
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the effectiveness of Chloral Hydrate in reducing insomnia severity
Description
Change in self-rated insomnia severity, assessed using the Insomnia Severity Index
Time Frame
Self-rated insomnia severity, assessed at baseline and 2 weeks
Secondary Outcome Measure Information:
Title
To explore whether Chloral Hydrate will affect Self-rated insomnia severity, assessed at baseline and 2 weeks
Description
Change in self-rated insomnia severity, assessed using the Insomnia Severity Index (ISI)
Time Frame
Self-rated insomnia severity, assessed at baseline, 1 week and 6 weeks
Title
To explore whether Chloral Hydrate will affect Daytime sleepiness
Description
Change in Epworth Sleepiness Scale scores which is based on a 0-3 scale with 0 being No chance of dozing, and 3 High chance of dozing.
Time Frame
Epworth Sleepiness Scale scores, assessed at baseline, 1 week, 2 weeks and 6 weeks
Title
To explore whether Chloral Hydrate will affect Insomnia severity
Description
Change in self-rated insomnia severity, assessed using the Insomnia Severity Index (ISI)
Time Frame
Self-rated insomnia severity, assessed at baseline, 1 week and 6 weeks
Title
To explore whether Chloral Hydrate will affect Health-related quality of life
Description
Change in health-related quality of life, measured using the ShortForm 36 (SF-36) and EQ-5D-5L questionnaires. The SF-36 is based on a 1-5 with 1 being excellent and 5 poor. EQ-5D-5L is scored on a 0-100 scale with 0being the worst health possible, and 100 the best health you can imagine.
Time Frame
SF-36 and EQ-5D-5L responses, assessed at baseline, 1 week, 2 weeks and 6 weeks
Title
To explore whether Chloral Hydrate will affect anxiety and Depression
Description
Change in Hospital Anxiety and Depression Scale (HADS) scores. The scale is based on a 0-21 scale with 0-7 = Normal, 8-10 = Borderline abnormal (borderline case), 11-21 = Abnormal (case)
Time Frame
HADS scores, assessed at baseline, 1 week, 2 weeks and 6 weeks
Title
To explore whether Chloral Hydrate will affect Quality of sleep and sleep disturbances
Description
Change in Pittsburgh Sleep Quality Index (PSQI) scores
Time Frame
PSQI responses assessed at baseline, 2 weeks and 6 weeks
Title
To investigate the safety of Chloral Hydrate
Description
Evaluation of overall safety of Chloral Hydrate by the monitoring of AEs and SAEs
Time Frame
AEs and SAEs for the 6 week trial duration
Title
To investigate intervention adherence
Description
Daily intervention adherence for the duration of the intervention (2 weeks)
Time Frame
Daily intervention adherence survey questions on days 1-14
Title
To assess tolerance of Chloral Hydrate
Description
Number of participants withdrawn from the IMP due to an AR, during the 2 week treatment period
Time Frame
Total number of participants withdrawn from the IMP due to an AR
Title
To determine any reductions in the use of non-pharmacological sleep therapies
Description
Change in use of non-pharmacological sleep therapies
Time Frame
Non-pharmacological sleep therapies assessed at baseline, 1 week, 2 weeks and 6 weeks
Title
To determine any reductions in 1. Concomitant prescribed medication 2. Over the counter medication used to facilitate sleep
Description
Change in Concomitant medication Over the counter medication used to facilitate sleep
Time Frame
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
Title
Medical doctor assessment of effectiveness of Chloral Hydrate
Description
Clinical Global Impressions - Severity Scale (CGI-S) assessed at baseline, and Clinical Global Impressions - Improvement scale (CGI-I) assessed after IMP treatment by the medically qualified doctor. Rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Time Frame
CGI-S assessed at baseline, and CGI-I assessed at 2 weeks and 6 weeks
Other Pre-specified Outcome Measures:
Title
To assess days off work
Description
Change in percentage of days off work
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luke Twelve
Phone
07730762086
Email
luke@lindushealth.com
Facility Information:
Facility Name
Lindus Health, The Leather Market Weston Street, Bermondsey,
City
London
ZIP/Postal Code
SE1 3ER
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Barrack
Phone
07422376972

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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