Phase 2
Completed N=32
AD109 Dose Finding in Mild to Moderate OSA
Source: ClinicalTrials.gov NCT04631107 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h] — -0.40; -0.21; 0.18 difference in log10HB[(%*min)/h]
Summary
This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h] |
-0.40; -0.21; 0.18 | — |
| PRIMARY Change in Hypoxic Burden (HB) Raw Values - HB[(%*Min)/h] |
-6.90; -4.70; 2.20 | — |
Eligibility Criteria
Inclusion Criteria
- AHI between 5 and 20 events/h
- PGI-S equal to or higher than 1, or one or more of the following symptoms:
- Snoring or nightime gasping/choking
- Daytime sleepiness, fatigue or decreased concentration
- Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning headache
- Irritability, decreased mood or libido
Exclusion Criteria
- History of narcolepsy.
- Clinically significant craniofacial malformation.
- Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
- CPAP should not be used for at least 2 weeks prior to the study
- History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
Data sourced from ClinicalTrials.gov (NCT04631107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.