DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.
← catalyst calendarNCT07635563 · readout ≤ 254 d
Sponsored by Incannex Healthcare Ltd (industry) · IXHL — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
120estimated
Sites
14
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-07-21 | actual | When the study began enrolling |
| Primary completion | Apr 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2026-06-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Obstructive Sleep Apnea (OSA)
Interventions
- Drug: IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide
- Drug: IHL-42X: 5 mg dronabinol + 125 mg acetazolamide
- Drug: IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide
- Drug: IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide
- Drug: IHL-42X: 5 mg dronabinol + 250 mg acetazolamide
- Drug: IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide
- Drug: IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide
- Drug: IHL-42X: 5 mg dronabinol + 375 mg acetazolamide
- Drug: IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide
- Drug: Placebo: Negative control
Primary outcome
what the primary-completion date above is the date OFChange in AHI4 at the end of each treatment period compared to baseline
measured Each treatment period (28 days)
Permalink · IXHL's whole pipeline · Catalyst calendar · Every registered study · What changed