Phase 2Recruiting
DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.
Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea
- Sponsor
- Incannex Healthcare Ltd (Industry)
- Enrolment
- 120 planned
- Conditions
- Obstructive Sleep Apnea (OSA)
- 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
- Ages
- adults, older adults
- Registry
- NCT07635563
Full record on ClinicalTrials.gov
From the registry
The goal of this randomized, double-blind, multi-dose crossover clinical trial is to determine the safety and efficacy 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). The study will consist of three separate four-way crossover dose-comparison studies each comparing three dose strengths of IHL-42X to placebo. The double-blind four-way crossover will be conducted according to a Williams design. Each of the crossover studies will test different doses of dronabinol in combination with a distinct, set dose of acetazolamide. In total, nine different combinations of dronabinol and acetazolamide formulated as IHL-42X will be tested in the study. The optimal dose strength will be selected based on safety and efficacy over a 4-week treatment period.
Primary outcomes
- Change in AHI4 at the end of each treatment period compared to baseline
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered