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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 Oct 19, 2026, 6:36 PM 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 28, 2023 (Actual)
Primary completion
May 7, 2025 (Actual)
Completion
May 7, 2025 (Actual)
Last update posted
Nov 21, 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 21, 2025 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05811247 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →