Artemis Institute for Clinical Research | Riverside, CA
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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Aged ≥18 years of age
Screening polysomnography (PSG) findings confirmed on central over-read:
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:
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:
A female will not be considered of childbearing potential if:
A male patient must agree to use at least 1 approved method of contraception (or as required by local regulations) while engaging in sexual activity from study Day -1 through End-of-Study (EOS) follow-up and/or up to 10 days following the last administration of the study drug. Male patients must not donate sperm during this same period. Approved methods of contraception include the following:
Voluntarily written consent to participate in the study and be willing and able to participate in all scheduled visits, treatment plans, tests, and other study procedures according to the protocol
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 sedative-hypnotics (ATC N05C) or stimulants (ATC N06B) to treat insomnia, OSA, and 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)
Severe depression, defined as a score of ≥30 on the Major Depression Inventory questionnaire
Severe anxiety, defined as score of >15 on the General Anxiety Disorder-7 questionnaire
Any of the following co-morbid conditions (Note: clarification on co-morbidities and inclusion/exclusion criteria may be discussed with the medical monitor and/or sponsor):
Other ongoing condition(s) that the investigator considers may be clinically significant with regards to the patient's safe participation in this study or may confound this study's findings; any consideration should be discussed with the medical monitor or with the sponsor
Participation in any other interventional studies involving investigational or marketed products within 30 days or 5.5 half-lives, whichever is longer, of the IP prior to screening. Patients in Phase II may enter screening (with a different identifier) for Phase III after 30 days from the last administration of the study drug in Phase II.
Primary purpose
Allocation
Interventional model
Masking
560 participants in 7 patient groups, including a placebo group
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Central trial contact
Amanda Sallama; Mark Bleackley
Data sourced from clinicaltrials.gov
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