RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA (NCT06146101) | Clinical Trial Compass
CompletedPhase 2/3
RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA
United States121 participantsStarted 2024-05-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged ≥18 years of age
. Screening polysomnography (PSG) findings confirmed on central over-read:
. AHI ≥15
. ≤ 25% central or mixed apneas/hypopneas
. no Cheyne-Stokes respiration
. total sleep time ≥ 2 hours
. Intolerant, non-compliant, or naïve to PAP (Note: No more than 25% of the study population will consist of PAP-naïve patients). Patients will be identified as intolerant, non-compliant, or naïve to PAP devices by the following criteria:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients are regarded as PAP-non-compliant if they do not use PAP for ≥ 4 hours for at least 21 nights during consecutive 30-day period based on data collected from the PAP device (eg, SD storage cards) and/or a cloud-based repository of PAP device data.
Exclusion criteria
. Body mass index \>45 kg/m2
. PAP-compliant, defined by the use of PAP for ≥ 4 hours for at least 21 nights during the consecutive 30-day period
. Current use of oral appliances (eg, mandibular advancement device, tongue retaining device, or mouth guard)
. Maxillomandibular advancement, upper airway, or bariatric surgery within the last 6 months prior to first administration of the study drug; or patients who are considering surgical treatment
. Use of benzodiazepines, sedative-hypnotics, or stimulants (ATC N06B, N05C, N05BA, N03AE, and N01AF categories) to treat insomnia, OSA, other sleep disorders
. Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy
. Chronic neuromuscular disorders such as motor neuron disease, muscular dystrophy, or myopathy
. Known allergic reaction to cannabis products with previous use