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IHL-42X for Obstructive Sleep Apnea (REPOSA Trial)

Phase 2 & 3

Recruiting

Research Sponsored by Incannex Healthcare Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Chronic neuromuscular disorders such as motor neuron disease, muscular dystrophy, or myopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Summary

This trial aims to test a new drug, IHL-42X, for people with obstructive sleep apnoea who cannot tolerate or comply with positive airway pressure treatment. The trial has two

Who is the study for?

This trial is for adults with moderate obstructive sleep apnea who either can't or won't use positive airway pressure (PAP) therapy. Participants should not have a significant portion of central or mixed apneas, no Cheyne-Stokes respiration, and must not use cannabis or similar drugs outside the study. They need to agree to contraception during and shortly after the trial.

What is being tested?

The RePOSA trial tests IHL-42X at different doses against placebo in two phases: Phase II finds the best dose over 4 weeks; Phase III compares this optimal dose to its components—dronabinol and acetazolamide—and placebo over a year.

What are the potential side effects?

Possible side effects may include those commonly associated with dronabinol (like dizziness, mood changes, and digestive issues) and acetazolamide (such as tingling sensations, diuresis, and potential metabolic effects).

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a chronic condition affecting my muscles or nerves.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in apnea-hypopnea index (AHI)

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Phase 3 Investigational Product - IHL-42XExperimental Treatment1 Intervention

IHL-42X (dose will be identified based on the safety and efficacy results in Phase II), one capsule self-administered once daily every night approximately 1 hour prior to bed for 52 weeks.

Group II: Phase 2 Investigational Product - IHL-42X Low doseExperimental Treatment1 Intervention

IHL-42X (2.5 mg dronabinol + 125 mg acetazolamide), one capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.

Group III: Phase 2 Investigational Product - IHL-42X High doseExperimental Treatment1 Intervention

IHL-42X (5 mg dronabinol + 250 mg acetazolamide), one capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.

Group IV: Phase 3 Comparator - Reference Listed Drug/DronabinolActive Control1 Intervention

One capsule of dronabinol (equivalent dose strength to that in the IHL-42X optimal dose strength) self-administered once daily every night approximately 1 hour prior to bed for 3 months then IHL-42X (optimal dose) one capsule self-administered once daily every night approximately 1 hour prior to bed for the remaining 9 months.

Group V: Phase 3 Comparator - Reference Listed Drug/AcetazolamideActive Control1 Intervention

One capsule of acetazolamide (equivalent dose strength to that in the IHL-42X optimal dose strength) self-administered once daily every night approximately 1 hour prior to bed for 3 months then IHL-42X (optimal dose) one capsule self-administered once daily every night approximately 1 hour prior to bed for the remaining 9 months.

Group VI: Phase 3 PlaceboPlacebo Group1 Intervention

One capsule self-administered once daily every night approximately 1 hour prior to bed for 52 weeks.

Group VII: Phase 2 PlaceboPlacebo Group1 Intervention

One capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.

0 / 1Eligibility criteria met