OSA
Conditions
Keywords
Obstructive Sleep Apnea
Brief summary
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
Interventions
DRUGAD109
Aroxybutynin 2.5 mg/atomoxetine 75 mg tablet, administered orally once daily at bedtime (Weeks 2-26). Week 1 run-in: aroxybutynin 2.5 mg/atomoxetine 37.5 mg tablet.
DRUGPlacebo
Matching placebo tablet administered orally once daily at bedtime for 26 weeks, with run-in and target dose matched to active arm packaging
Sponsors
Apnimed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years of age at the time of informed consent. 2. PSG criteria: AHI of ≥10 and ≤45; ≤ 25% central or mixed apneas; and PLM arousal index ≤15 3. PROMIS-Fatigue: raw score ≥17 4. PAP intolerance or current PAP refusal. 5. BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive.
Exclusion criteria
1. Narcolepsy, restless leg syndrome, REM sleep behavior disorder 2. Insomnia disorder characterized by difficulty initiating or maintaining sleep, or use within the past month of sedative-hypnotics or other medication for the purpose of treating or avoiding insomnia symptoms. 3. Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy. 4. Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed. 5. Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Apnea-Hypopnea Index (AHI) | 6 months | AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO2) by at least 4%. |
Countries
Canada, United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.5 years STANDARD_DEVIATION 10.67 |
| Baseline AHI4 | 22.13 events/hr STANDARD_DEVIATION 11.819 |
| Baseline AHI4 group <15 | 105 Participants |
| Baseline AHI4 group 15 - 30 | 134 Participants |
| Baseline AHI4 group >30 | 70 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 45 Participants |
| Race (NIH/OMB) Black or African American | 117 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 212 Participants |
| Sex: Female, Male Female | 153 Participants |
| Sex: Female, Male Male | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 325 | 0 / 319 |
| other Total, other adverse events | 176 / 325 | 50 / 319 |
| serious Total, serious adverse events | 5 / 325 | 8 / 319 |
Outcome results
None listed