Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide for Obstructive Sleep Apnea (OSA)

The goal of this randomly assigned, neither you nor the study doctors know who gets the real treatment, multi-dose crossover clinical trial is to determine the safety and how well it works of IHL-42X in subjects with obstructive sleep apnea. The primary endpoint is: Change in AHI4 at the end of each treatment period compared to baseline (each treatment period is 28 days).

Official registry: https://clinicaltrials.gov/study/NCT07635563 · Incannex Healthcare Ltd · enrollment listed as 120

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide, IHL-42X: 5 mg dronabinol + 125 mg acetazolamide, or IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide. The registry lists allocation as randomized. The goal of this randomly assigned, neither you nor the study doctors know who gets the real treatment, multi-dose crossover clinical trial is to determine the safety and how well it works of IHL-42X in subjects with obstructive sleep apnea.

They plan to enroll about 120 people at 13 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea

Interventions: IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide, IHL-42X: 5 mg dronabinol + 125 mg acetazolamide, IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide, IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide, IHL-42X: 5 mg dronabinol + 250 mg acetazolamide, IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide, IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide, IHL-42X: 5 mg dronabinol + 375 mg acetazolamide, IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide, Placebo: Negative control

Primary outcome (registry wording): Change in AHI4 at the end of each treatment period compared to baseline

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • Participants must satisfy all the following criteria at screening unless otherwise stated:
  • Aged ≥18 and ≤65 years of age at the time of consent
  • Two screening PSG findings confirmed on central over-read that both must meet the below criteria:
  • ≤25% central or mixed apneas out of total AHI
  • no Cheyne-Stokes respiration
  • total sleep time ≥ 4 hours in each PSG
  • \< 30 periodic leg movement disorder arousals per hour

Public study contact (from the registry)

Mark Bleackley

+61 2 9634 4508

mark@incannex.com.au

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

13 listed

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FAQ about this NCT record

Is NCT07635563 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07635563?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07635563?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary