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NCT06146101 · ClinicalTrials.gov registry record · Phase 2
RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA
A Phase 2 study of Obstructive Sleep Apnea, sponsored by Incannex Healthcare.
- Active
- Registry status
- Phase 2
- Development phase
- 560
- Enrollment target
- 20
- Study locations
NCT06146101: Active Phase 2 study of Obstructive Sleep Apnea, sponsored by Incannex Healthcare.
NCT06146101 is a Phase 2 study of Obstructive Sleep Apnea that is active but no longer recruiting, run by Incannex Healthcare. The registered enrollment target is 560 participants, above the 218-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (157% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06146101, a Phase 2 study of Obstructive Sleep Apnea, is active but no longer recruiting, sponsored by Incannex Healthcare.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 560 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Phase 2 - Assess the change in AHI compared to baseline
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 |
What the registry record for NCT06146101 still lists
NCT06146101 is an interventional study that assigns participants to a tested intervention. The registered 560 participants enrollment target is mid-sized for trials with a published cap, above the 218-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (157% higher).
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.
NCT06146101 names 20 study sites across 11 states, led by Florida, California, Maryland.
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.
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).
Who is sponsoring clinical trial NCT06146101?
This trial is sponsored by Incannex Healthcare, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06146101's enrollment target sits among peer trials
560 12th of 155 higher than 144 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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