The goal of this randomized, double-blind, multi-dose crossover clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnea. The primary endpoint is: Change in AHI4 at the end of each treatment period compared to baseline (each treatment period is 28 days). The study will consist of three separate four-way crossover dose-comparison studies each comparing three dose strengths of IHL-42X to placebo. The double-blind four-way crossover will be conducted according to a Williams design. Each of the crossover studies will test different doses of dronabinol in combination with a distinct, set dose of acetazolamide. In total, nine different combinations of dronabinol and acetazolamide formulated as IHL-42X will be tested in the study. The optimal dose strength will be selected based on safety and efficacy over a 4-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 1
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 2
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 3
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 4
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 5
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 6
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 7
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 8
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 9
DReAMzz Phase 2 Placebo
Exalt Clinical Research
Chula Vista, California, United States
Teradan Clinical Trials LLC
Brandon, Florida, United States
CNS Healthcare - Jacksonville
Jacksonville, Florida, United States
CNS Healthcare Orlando
Orlando, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Conquest Research/Neurotrials
Winter Park, Florida, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Velocity Clinical Research, Rockville
Rockville, Maryland, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Intrepid Research
Cincinnati, Ohio, United States
...and 4 more locations
Change in AHI4 at the end of each treatment period compared to baseline
To assess the change in efficacy at the end of each dosing period compared with baseline.
Time frame: Each treatment period (28 days)
Percent change in AHI4 at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Change in Functional Outcomes of Sleep Questionnaire 10-items (FOSQ-10) at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Change in Patient-reported outcome measurement information system (PROMIS)-Fatigue 7a at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Change in Patient-reported outcome measurement information system - Sleep Related Impairment (PROMIS-SRI) 8a at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Change in Patient Global Impression of Severity (PGI-S) the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Patient Global Impression of Change (PGI-C) score at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Change in Patient-reported Longitudinal Assessment Tool for OSA-11 item (PLATO) at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Change in Epworth Sleepiness Scale (ESS) at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Change in Oxygen Desaturation Index (ODI) (from PSG) at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Change in hypoxic burden at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Percent of participants whose OSA severity reduces by one or more levels with severe OSA AHI4 ≥30, moderate OSA AHI4 15-30, mild OSA AHI4 <15
Time frame: 140 days
Percent of participants with ≥50% reduction in AHI4
Time frame: 140 days
Percent of participants with AHI4 <5
Time frame: 140 days
Adverse events and treatment-emergent adverse events (TEAEs), clinically significant out of range values or findings from clinical laboratory test results, electrocardiogram (ECG), vital signs, and physical examinations
To evaluate the safety and tolerability of IHL-42X
Time frame: 140 days
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