AD109 Dose Finding in Mild to Moderate OSA

Phase 2 Completed 32 enrolled Apnimed

RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start: 2020-12-22
Primary completion: 2021-05-31
Completion: 2021-05-31

Outcome

Met primary endpoint

paper hypoxic burden for participants on placebo was 13.9[4.5-21.9] (%min)/h vs 2.3[0.1-10.5] (%min)/h for patients on the high dose (P < .001) PMID 35975547 ↗

Publications

Results Rosenberg R, Abaluck B, Thein S. Combination of atomoxetine with the novel antimuscarinic aroxybutynin improves mild to moderate OSA. J Clin Sleep Med. 2022 Dec 1;18(12):2837-2844. doi: 10.5664/jcsm.10250.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aroxybutynin	Small molecule	2.5 mg	Oral
Subject	Atomoxetine	Other / unclassified	37.5 mg	Oral
Subject	Atomoxetine	Other / unclassified	75 mg	Oral