AD109 Dose Finding in Mild to Moderate OSA

Completed · Phase 2 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT04631107

Run by

Apnimed

People needed

32

Starts

2020-12-22

Expected to finish

2021-05-31

Last updated by the study team

2022-12-22

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Pacific Research Network — San Diego, California, United States
• NeuroTrial Research — Atlanta, Georgia, United States
• Brian Abaluck, LLC — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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