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Completed Phase 3 Interventional

Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)

ClinicalTrials.gov ID: NCT05811247

Public ClinicalTrials.gov record NCT05811247. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 9:24 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05811247
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Apnimed
Industry
Enrollment
660 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 27, 2023
Primary completion
May 6, 2025
Completion
May 6, 2025
Last update posted
Nov 20, 2025

2023 – 2025

United States locations

U.S. sites
64
U.S. states
26
U.S. cities
62
Facility City State ZIP Site status
Sleep Disorders Center of Alabama Birmingham Alabama 35213
Chandler Clinical Trials Chandler Arizona 85224
Preferred Research Partners, Inc. Little Rock Arkansas 72211
Orange County Research Institute Anaheim California 92801
Marvel Clinical Research, LLC Huntington Beach California 92647
CenExel CNS Los Alamitos California 90720
Santa Monica Clinical Trials Los Angeles California 90025
Empire Clinical Research Pomona California 91767
Pacific Research Network San Diego California 92103
SDS Clinical Trials Inc. Santa Ana California 92705
Alpine Clinical Research Center Boulder Colorado 80301
Mountain View Clinical Research, Inc. Denver Colorado 80209
Nuvance Health Norwalk Connecticut 06850
Teradan Clinical trials LLC Brandon Florida 33511
St. Francis Medical Institute Clearwater Florida 33765
Nouvelle Clinical Research Cutler Bay Florida 33189
Arrow Clinical Trials Daytona Beach Florida 32117
Cenexel Research Centers of America - Hollywood Hollywood Florida 33024
Ivetmar Medical Group LLC Miami Florida 33155
PharmaDev Clinical Research Institute, LLC Miami Florida 33176
Renstar Medical Research Ocala Florida 34470
Palm Beach Research ClinEdge-PPDS West Palm Beach Florida 33409
Clinical Site Partners, LLC dba Flourish Research Winter Park Florida 32789
NeuroTrials Research Atlanta Georgia 30328
CenExel iResearch Decatur Georgia 30030
Sleep Practitioners, LLC Macon Georgia 31210
Centricity Research Rincon Pulmonology Rincon Georgia 31326
Medster Research Valdosta Georgia 31605
Chicago Research Center Inc Chicago Illinois 60634
Sleep Disorders Centers of the Mid-Atlantic Glen Burnie Maryland 21061
Velocity Clinical Research Rockville Maryland 20854
Neurocare, Inc Newton Massachusetts 02459
Infinity Medical Research North Dartmouth Massachusetts 02747
Baystate Medical Center (BMC) - Baystate Sleep Medicine Springfield Massachusetts 01199
Western Michigan University Homer Stryker M.D. School of Medicine Kalamazoo Michigan 49008
Henry Ford Health (Sleep Research Department) Novi Michigan 48377
Clinical Neurophysiology Services Sterling Heights Michigan 48314
St Lukes Hospital Chesterfield Missouri 63017
Healthcare Research Network Hazelwood Missouri 63042
Clayton Sleep Institute St Louis Missouri 63123
Great Plains Health North Platte Nebraska 69101
Henderson Clinical Trials Henderson Nevada 89052
Clinilabs, Inc Eatontown New Jersey 07724
Maimonides Sleep Arts and Sciences Albuquerque New Mexico 87107
Northwell Health Physician Partners New Hyde Park New York 11042
Research Carolina Elite Denver North Carolina 28037
Clinical Research of Gastonia Gastonia North Carolina 28054
Advanced Respiratory and Sleep Medicine, LLC Huntersville North Carolina 28078
Coastal Carolina Health Care New Bern North Carolina 28562
Meridian Clinical Research Raleigh North Carolina 27607
NeuroScience Research Center, LLC Canton Ohio 44718
CTI Clinical Research Center Cincinnati Ohio 45212
Sleep Management Institute Cincinnati Ohio 45245
Ohio Sleep Medicine Institute Dublin Ohio 43017
Northwest Research Center Portland Oregon 97202
Brian Abaluck, LLC Malvern Pennsylvania 19355
UPMC Comprehensive Lung Center - Sleep Medicine Pittsburgh Pennsylvania 15213
Lowcountry Lung and Critical Care Charleston South Carolina 29406
Velocity Clinical Research - Greenville Greenville South Carolina 29615
Clinical Neuroscience Solutions - Memphis Memphis Tennessee 38119
FutureSearch Trials of Neurology Austin Texas 78731
Central Texas Neurology Consultants, PA Round Rock Texas 78681
Sleep Therapy Research Center San Antonio Texas 78229
Sleep Disorders Centers of the Mid-Atlantic Vienna Virginia 22182

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05811247, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 20, 2025 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05811247 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →