RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA
REPOSA
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
2 other identifiers
interventional
560
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2024
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2023
CompletedFirst Posted
Study publicly available on registry
November 24, 2023
CompletedStudy Start
First participant enrolled
May 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 20, 2025
February 1, 2025
2.6 years
November 17, 2023
April 16, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in apnea-hypopnea index (AHI)
Phase 2 - Assess the change in AHI compared to baseline
4 weeks
Change in apnea-hypopnea index (AHI)
Phase 3 - Assess the change in AHI compared to baseline
52 weeks
Study Arms (7)
Phase 2 Investigational Product - IHL-42X Low dose
EXPERIMENTALIHL-42X (2.5 mg dronabinol + 125 mg acetazolamide), one capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
Phase 2 Investigational Product - IHL-42X High dose
EXPERIMENTALIHL-42X (5 mg dronabinol + 250 mg acetazolamide), one capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
Phase 2 Placebo
PLACEBO COMPARATOROne capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
Phase 3 Investigational Product - IHL-42X
EXPERIMENTALIHL-42X (dose will be identified based on the safety and efficacy results in Phase II), one capsule self-administered once daily every night approximately 1 hour prior to bed for 52 weeks.
Phase 3 Comparator - Reference Listed Drug/Dronabinol
ACTIVE COMPARATOROne capsule of dronabinol (equivalent dose strength to that in the IHL-42X optimal dose strength) self-administered once daily every night approximately 1 hour prior to bed for 3 months then IHL-42X (optimal dose) one capsule self-administered once daily every night approximately 1 hour prior to bed for the remaining 9 months.
Phase 3 Comparator - Reference Listed Drug/Acetazolamide
ACTIVE COMPARATOROne capsule of acetazolamide (equivalent dose strength to that in the IHL-42X optimal dose strength) self-administered once daily every night approximately 1 hour prior to bed for 3 months then IHL-42X (optimal dose) one capsule self-administered once daily every night approximately 1 hour prior to bed for the remaining 9 months.
Phase 3 Placebo
PLACEBO COMPARATOROne capsule self-administered once daily every night approximately 1 hour prior to bed for 52 weeks.
Interventions
Softgel capsule
Softgel capsule
Softgel capsule
Softgel capsule
Softgel capsule
Eligibility Criteria
You may qualify if:
- 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:
- 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.
- Patients are regarded as PAP-intolerant if they are former PAP users, ie, a PAP device that they have not used for \>30 days or who do not have access to PAP device
- Patients are regarded as PAP-naïve if they have no prior experience with PAP. Patients who have undergone a split-study, ie, a study of PAP during PSG, are not considered PAP- naïve and should be categorised according to a through b above. (Note: PAP-naïve patients will have the benefits and risks of PAP explained at screening, including that PAP is standard of care for OSA. These patients also have the option to withdraw from the study at any time if he/she elects to be treated with PAP or other alternative therapy such as an oral appliance or surgery)
- Must agree not to take any form of cannabis or cannabinoid, or any other illicit or recreational drug with the exception of the investigational product (IP) while participating in this study.
- A female patient of childbearing potential must agree to use 2 approved methods of contraception. Approved methods of contraception include the following:
- Intra-uterine device in place for at least 3 months prior to Day 1 through to 10 days following the last dose of the study drug
- Barrier method (condom or diaphragm) for at least 3 months prior to Day 1 through to 10 days after the last dose of the study drug
- Stable hormonal contraceptive which includes oral, intravaginal, intrauterine, transdermal, injectable, or implantable methods of hormonal contraception for at least 3 months prior to Day 1.
- +7 more criteria
You may not qualify if:
- 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
- Known allergic reaction to sesame oil
- Known allergic reaction to acetazolamide
- Pregnant or breast-feeding
- Current illicit drug abuse (within the last 6 months prior to screening) ; "abuse" has some subsets that are objective and some that require investigator judgement; questions should be discussed with the medical monitor or with the sponsor
- An objective subset includes consumption of substances that are "illicit", i.e. not legal per local laws
- Investigator judgement is expected for legally marketed products ingested for other than the approved indication(s)
- Severe depression, defined as a score of ≥30 on the Major Depression Inventory questionnaire
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Exalt Clinical Research
Chula Vista, California, 91910, United States
CenExel CNS- Los Alamitos
Long Beach, California, 90806, United States
Pacific Clinical Research Medical Group
Upland, California, 91786-4985, United States
Clinical Neuroscience Solutions, Inc. (CNS Healthcare of Jacksonville)
Jacksonville, Florida, 32256, United States
Clinical Neuroscience Solutions, Inc. (CNS Healthcare of Orlando)
Orlando, Florida, 32806, United States
Teradan Clinical Trials
Valrico, Florida, 33596-8262, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409-3401, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, 30328, United States
Tandem Clinical Research, LLC
Marrero, Louisiana, 70072, United States
Centennial Medical Group
Elkridge, Maryland, 21075-6434, United States
Meridian Clinical Research, LLC
Rockville, Maryland, 20854, United States
Henderson Clinical Trials,LLC
Henderson, Nevada, 89052-5016, United States
Advanced Respiratory and Sleep Medicine, PLLC
Huntersville, North Carolina, 28078, United States
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, 45212, United States
Intrepid Research
Cincinnati, Ohio, 45245-4501, United States
Velocity Clinical Research - Anderson
Anderson, South Carolina, 29621, United States
Velocity Clinical Research - Greenville
Greenville, South Carolina, 29615, United States
Clinical Neuroscience Solutions, Inc. (CNS Healthcare of Memphis)
Memphis, Tennessee, 38119, United States
FutureSearch Trials
Austin, Texas, 78731, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231-3442, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2023
First Posted
November 24, 2023
Study Start
May 2, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 20, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share