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RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA
NCT06146101 · View on ClinicalTrials.gov ↗
Study Summary
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 will enrol approximately 165 patients in IHL-42X, approximately 55 patients in dronabinol, approximately 55 in acetazolamide, and approximately 165 in placebo, for a total of approximately 440 patients.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dronabinol
- DRUG IHL-42X Low Dose
- DRUG IHL-42X High Dose
- DRUG IHL-42X (Optimal Dose)
Study Locations (20)
Florida
- Clinical Neuroscience Solutions, Inc. (CNS Healthcare of Jacksonville) — Jacksonville
- Clinical Neuroscience Solutions, Inc. (CNS Healthcare of Orlando) — Orlando
- Teradan Clinical Trials — Valrico
- Palm Beach Research Center — West Palm Beach
California
- Exalt Clinical Research — Chula Vista
- CenExel CNS- Los Alamitos — Long Beach
- Pacific Clinical Research Medical Group — Upland
Maryland
- Centennial Medical Group — Elkridge
- Meridian Clinical Research, LLC — Rockville
Ohio
- CTI Clinical Trial and Consulting Services — Cincinnati
- Intrepid Research — Cincinnati
South Carolina
- Velocity Clinical Research - Anderson — Anderson
- Velocity Clinical Research - Greenville — Greenville
Texas
- FutureSearch Trials — Austin
- FutureSearch Trials of Dallas, LP — Dallas
Georgia
- NeuroTrials Research, Inc. — Atlanta
Louisiana
- Tandem Clinical Research, LLC — Marrero
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 560 participants |
| Start Date | 2024-05-02 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06146101
The ClinicalTrials.gov registry entry for NCT06146101 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 560 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incannex Healthcare, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06146101 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06146101 about?
NCT06146101 is a clinical study titled "RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA". 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 tw...
What is the current status of trial NCT06146101?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 560 participants. The study started on 2024-05-02. Estimated completion is 2026-12.
What conditions does trial NCT06146101 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06146101?
The interventions under investigation include: Placebo (DRUG), Dronabinol (DRUG), IHL-42X Low Dose (DRUG), IHL-42X High Dose (DRUG), IHL-42X (Optimal Dose) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06146101?
This trial is sponsored by Incannex Healthcare, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06146101 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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