RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA
Public ClinicalTrials.gov record NCT06146101. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II/III, Randomised, Double-Blind Clinical Trial 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06146101
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 121 participants
Conditions and interventions
Conditions
Interventions
- IHL-42X Low Dose Drug
- IHL-42X High Dose Drug
- Placebo Drug
- IHL-42X (Optimal Dose) Drug
- Dronabinol Drug
- Acetazolamide Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 1, 2024
- Primary completion
- May 19, 2025
- Completion
- Jul 26, 2025
- Last update posted
- Jul 26, 2026
2024 – 2025
United States locations
- U.S. sites
- 20
- U.S. states
- 11
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Exalt Clinical Research | Chula Vista | California | 91910 | — |
| CenExel CNS- Los Alamitos | Long Beach | California | 90806 | — |
| Pacific Clinical Research Medical Group | Upland | California | 91786-4985 | — |
| Clinical Neuroscience Solutions, Inc. (CNS Healthcare of Jacksonville) | Jacksonville | Florida | 32256 | — |
| Clinical Neuroscience Solutions, Inc. (CNS Healthcare of Orlando) | Orlando | Florida | 32806 | — |
| Teradan Clinical Trials | Valrico | Florida | 33596-8262 | — |
| Palm Beach Research Center | West Palm Beach | Florida | 33409-3401 | — |
| NeuroTrials Research, Inc. | Atlanta | Georgia | 30328 | — |
| Tandem Clinical Research, LLC | Marrero | Louisiana | 70072 | — |
| Centennial Medical Group | Elkridge | Maryland | 21075-6434 | — |
| Meridian Clinical Research, LLC | Rockville | Maryland | 20854 | — |
| Henderson Clinical Trials,LLC | Henderson | Nevada | 89052-5016 | — |
| Advanced Respiratory and Sleep Medicine, PLLC | Huntersville | North Carolina | 28078 | — |
| CTI Clinical Trial and Consulting Services | Cincinnati | Ohio | 45212 | — |
| Intrepid Research | Cincinnati | Ohio | 45245-4501 | — |
| Velocity Clinical Research - Anderson | Anderson | South Carolina | 29621 | — |
| Velocity Clinical Research - Greenville | Greenville | South Carolina | 29615 | — |
| Clinical Neuroscience Solutions, Inc. (CNS Healthcare of Memphis) | Memphis | Tennessee | 38119 | — |
| FutureSearch Trials | Austin | Texas | 78731 | — |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231-3442 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06146101, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 26, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06146101 live on ClinicalTrials.gov.