DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.
Sponsor: Incannex Healthcare Ltd • ClinicalTrials.gov ID: NCT07635563
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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.
Interventions
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IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide
(Drug)
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 1
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IHL-42X: 5 mg dronabinol + 125 mg acetazolamide
(Drug)
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 2
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IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide
(Drug)
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 3
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IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide
(Drug)
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 4
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IHL-42X: 5 mg dronabinol + 250 mg acetazolamide
(Drug)
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 5
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IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide
(Drug)
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 6
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IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide
(Drug)
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 7
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IHL-42X: 5 mg dronabinol + 375 mg acetazolamide
(Drug)
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 8
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IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide
(Drug)
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 9
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Placebo: Negative control
(Drug)
DReAMzz Phase 2 Placebo
Eligibility criteria
Conditions
Locations
- Exalt Clinical Research — Chula Vista, California, United States
- Teradan Clinical Trials LLC — Brandon, Florida, United States
- CNS Healthcare - Jacksonville — Jacksonville, Florida, United States
- CNS Healthcare Orlando — Orlando, Florida, United States
- Palm Beach Research Center — West Palm Beach, Florida, United States
- Tandem Clinical Research — Marrero, Louisiana, United States
- Velocity Clinical Research, Rockville — Rockville, Maryland, United States
- CTI Clinical Research Center — Cincinnati, Ohio, United States
- Intrepid Research — Cincinnati, Ohio, United States
- Velocity Clinical Research, Anderson — Anderson, South Carolina, United States
- CNS Healthcare - Memphis — Memphis, Tennessee, United States
- FutureSearch Trials of Dallas — Dallas, Texas, United States
- Sleep Therapy & Research Center — San Antonio, Texas, United States
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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