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Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)
Sponsor: Apnimed
Summary
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
Official title: Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (LunAIRo Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
660
Start Date
2023-08-28
Completion Date
2025-05-07
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
AD109
Aroxybutynin 2.5 mg/atomoxetine 75 mg tablet, administered orally once daily at bedtime (Weeks 2-51). Week 1 run-in: aroxybutynin 2.5 mg/atomoxetine 37.5 mg tablet.
Placebo
Matching placebo tablet administered orally once daily at bedtime for 51 weeks, with run-in and target dose matched to active arm packaging.
Locations (64)
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Chandler Clinical Trials
Chandler, Arizona, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Orange County Research Institute
Anaheim, California, United States
Marvel Clinical Research, LLC
Huntington Beach, California, United States
CenExel CNS
Los Alamitos, California, United States
Santa Monica Clinical Trials
Los Angeles, California, United States
Empire Clinical Research
Pomona, California, United States
Pacific Research Network
San Diego, California, United States
SDS Clinical Trials Inc.
Santa Ana, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Mountain View Clinical Research, Inc.
Denver, Colorado, United States
Nuvance Health
Norwalk, Connecticut, United States
Teradan Clinical trials LLC
Brandon, Florida, United States
St. Francis Medical Institute
Clearwater, Florida, United States
Nouvelle Clinical Research
Cutler Bay, Florida, United States
Arrow Clinical Trials
Daytona Beach, Florida, United States
Cenexel Research Centers of America - Hollywood
Hollywood, Florida, United States
Ivetmar Medical Group LLC
Miami, Florida, United States
PharmaDev Clinical Research Institute, LLC
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Palm Beach Research ClinEdge-PPDS
West Palm Beach, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, United States
NeuroTrials Research
Atlanta, Georgia, United States
CenExel iResearch
Decatur, Georgia, United States
Sleep Practitioners, LLC
Macon, Georgia, United States
Centricity Research Rincon Pulmonology
Rincon, Georgia, United States
Medster Research
Valdosta, Georgia, United States
Chicago Research Center Inc
Chicago, Illinois, United States
Sleep Disorders Centers of the Mid-Atlantic
Glen Burnie, Maryland, United States
Velocity Clinical Research
Rockville, Maryland, United States
Neurocare, Inc
Newton, Massachusetts, United States
Infinity Medical Research
North Dartmouth, Massachusetts, United States
Baystate Medical Center (BMC) - Baystate Sleep Medicine
Springfield, Massachusetts, United States
Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, United States
Henry Ford Health (Sleep Research Department)
Novi, Michigan, United States
Clinical Neurophysiology Services
Sterling Heights, Michigan, United States
St Lukes Hospital
Chesterfield, Missouri, United States
Healthcare Research Network
Hazelwood, Missouri, United States
Clayton Sleep Institute
St Louis, Missouri, United States
Great Plains Health
North Platte, Nebraska, United States
Henderson Clinical Trials
Henderson, Nevada, United States
Clinilabs, Inc
Eatontown, New Jersey, United States
Maimonides Sleep Arts and Sciences
Albuquerque, New Mexico, United States
Northwell Health Physician Partners
New Hyde Park, New York, United States
Research Carolina Elite
Denver, North Carolina, United States
Clinical Research of Gastonia
Gastonia, North Carolina, United States
Advanced Respiratory and Sleep Medicine, LLC
Huntersville, North Carolina, United States
Coastal Carolina Health Care
New Bern, North Carolina, United States
Meridian Clinical Research
Raleigh, North Carolina, United States
NeuroScience Research Center, LLC
Canton, Ohio, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Sleep Management Institute
Cincinnati, Ohio, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, United States
Northwest Research Center
Portland, Oregon, United States
Brian Abaluck, LLC
Malvern, Pennsylvania, United States
UPMC Comprehensive Lung Center - Sleep Medicine
Pittsburgh, Pennsylvania, United States
Lowcountry Lung and Critical Care
Charleston, South Carolina, United States
Velocity Clinical Research - Greenville
Greenville, South Carolina, United States
Clinical Neuroscience Solutions - Memphis
Memphis, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Central Texas Neurology Consultants, PA
Round Rock, Texas, United States
Sleep Therapy Research Center
San Antonio, Texas, United States
Sleep Disorders Centers of the Mid-Atlantic
Vienna, Virginia, United States