Status:
RECRUITING
A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia.
Lead Sponsor:
Woolcock Institute of Medical Research
Conditions:
Insomnia
Eligibility:
All Genders
40-65 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to explore the potential neuroprotective benefits of a dual orexin receptor antagonist (DORA) in adults with insomnia. The main questions it aims to answer are: * D...
Detailed Description
This is a randomised placebo-controlled cross-over study of a dual orexin receptor antagonist (DORA) versus placebo in adults with insomnia. To be enrolled in the study, participants are required to ...
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of insomnia disorder as defined by the DSM-5 (difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week, for at least 3 months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty) and a score ≥15 on the ISI.
- Able to provide informed electronic consent.
- Fluent English literacy.
- Adults aged between 40-65 years.
Exclusion Criteria:
- People highly dependent on medical care as determined by a medical officer.
- Untreated moderate-severe sleep apnoea as diagnosed using in-home wrist oximetry (oxygen desaturation index>15, ongoing effectively treated sleep apnoea with insomnia will be allowed).
- Circadian disorders, narcolepsy, severe restless legs syndrome, and REM sleep behaviour disorder or uncontrolled psychiatric disorders.
- History of attempted suicide or current suicide ideation (indicated by a score >0 on Q9 of the Patient Health Questionnaire-9) at pre-screening.
- Objective cognitive decline measured by scoring ≤26 on the Montreal Cognitive Assessment (MoCA)
- Regular shift work, jet lag or trans-meridian travel (over 2h time difference) in the past week before randomisation.
- Pregnancy or lactation. Women will be advised to use contraception for the duration of the study and a urine pregnancy test will be performed when necessary.
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical trial due to safety concerns or compliance with clinical study procedures.
- Currently participating in or has participated in a research study of an investigational agent or device within 4 weeks of enrolment.
- Concomitant use of medicines that are inhibitors (e.g., diltiazem, fluvoxamine, fluconazole, itraconazole, verapamil), or moderate to strong inducers of CYP3A4 (e.g., carbamazepine, modafinil, phenytoin, rifampicin, St John's Wort)
- Ongoing use of anti-psychotic medication, bosentan, efavirenz, etravirine, modafinil, rifampin, carbamazepine or illicit stimulants.
- Regular use of hypnotics (including melatonin, valerian, kava, benzodiazepines and Z-drugs), and other medications that can cause additive sedation (e.g. sedating antihistamines, tricyclic antidepressants, antipsychotics) within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.
- Regular use of psychostimulants (e.g., dexamfetamine, lisdexamfetamine, methylphenidate) or non-amphetamine psychostimulants (e.g., armodafinil, modafinil, atomoxetine) within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.
- Use of antidepressant medications for treatment of low mood for less than one year or dose changes (escalation or tapering) or change in antidepressant medications within the past year.
- Regular use opioids within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.
- Ongoing use of THC- or CBD-containing products within 14 days prior to the start of the trial.
- Dependence or any other drug or alcohol dependence within the past two years (alcohol to be limited to no more than 2 standard drinks per day during trial period).
- Allergy to lactose.
Key Trial Info
Start Date :
May 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06823752
Start Date
May 13 2025
End Date
April 1 2026
Last Update
October 3 2025
Active Locations (1)
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1
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia, 2113