EICHORCondition: Obstructive Sleep Apnea · Sponsor: Incannex Healthcare Ltd
The goal of this randomised, double-blind phase II/III clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnoea who are intolerant, non-compliant, or naïve to positive airway pressure. Phase II study will be a 4-week dose-finding study comparing two dose strengths of IHL-42X to placebo. The optimal dose strength will be selected based on comparing the safety and efficacy of the two IHL-42X dose strengths to placebo over a 4-week treatment period. The three treatment groups are; IHL-42X Low dose (2.5mg dronabinol, 125mg acetazolamide), IHL-42X High dose (5mg dronabinol, 250mg acetazolamide) and Placebo. Each treatment group will enrol approximately 40 patients per treatment arm, for a total of approximately 120 patients. The safety and efficacy results of the Phase II study will be used to select the dose strength of IHL-42X and corresponding doses of dronabinol and acetazolamide in Phase III. Phase III study will use the optimal dose strength of IHL-42X identified in Phase II and will be compared to the component active pharmaceutical ingredients at equivalent dose strengths to those found in the IHL-42X optimal dose strength and placebo over 52 weeks. The four treatment groups are; IHL-42X (optimal dose from Phase II), Acetazolamide (equivalent dose strength to that in the IHL-42X optimal dose strength), Dronabinol (equivalent dose strength to that in the IHL-42X optimal dose strength) and placebo. The treatment groups wi…
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| Exalt Clinical Research | Chula Vista, California, United States | — |
| CenExel CNS- Los Alamitos | Long Beach, California, United States | — |
| Pacific Clinical Research Medical Group | Upland, California, United States | — |
| Clinical Neuroscience Solutions, Inc. (CNS Healthcare of Jacksonville) | Jacksonville, Florida, United States | — |
| Clinical Neuroscience Solutions, Inc. (CNS Healthcare of Orlando) | Orlando, Florida, United States | — |
| Teradan Clinical Trials | Valrico, Florida, United States | — |
| Palm Beach Research Center | West Palm Beach, Florida, United States | — |
| NeuroTrials Research, Inc. | Atlanta, Georgia, United States | — |
| Tandem Clinical Research, LLC | Marrero, Louisiana, United States | — |
| Centennial Medical Group | Elkridge, Maryland, United States | — |
| Meridian Clinical Research, LLC | Rockville, Maryland, United States | — |
| Henderson Clinical Trials,LLC | Henderson, Nevada, United States | — |
+ 8 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06146101