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Phase 2 Investigational Product - IHL-42X High dose 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
A female patient of childbearing potential must agree to use 2 approved methods of contraception
Aged ≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
REPOSA Trial 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.Check my eligibility
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.See study design
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).
REPOSA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use two forms of birth control.
Select...
I am 18 years old or older.
REPOSA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in apnea-hypopnea index (AHI)
REPOSA 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.
Find a Location
Who is running the clinical trial?
Incannex Healthcare LtdLead Sponsor
2 Previous Clinical Trials
244 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are multiple medical facilities in the United States involved in conducting this research?
"At present, this medical investigation is operational in 25 distinct sites. Notable locations include Riverside, Phoenix, and Chula Vista alongside an additional 22 undisclosed areas. Opting for a nearby site may reduce the travel burden should you decide to take part."
Answered by AI
Are researchers actively seeking participants for this medical study?
"Per information from clinicaltrials.gov, this particular research study is not presently seeking participants. It was initially listed on April 1st, 2024 and last revised on April 29th, 2024. Despite its closure to new entrants, there are currently a total of 273 other active trials inviting enrolment for interested individuals."
Answered by AI
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