Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)

November 18, 2025 updated by: Apnimed

Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (SynAIRgy Study)

This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

646

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2Z 3R6
        • Canadian Sleep Consultants
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 9N7
        • Medical Arts Health Research
    • Ontario
      • Markham, Ontario, Canada, L3R 1A3
        • AMNDX
      • Ottawa, Ontario, Canada, K2C 0P7
        • West Ottawa Sleep Centre
      • Toronto, Ontario, Canada, M3J 0K2
        • Canadian Phase Onward Inc.
      • Toronto, Ontario, Canada, M4P 1P2
        • Toronto Sleep Institute
      • Toronto, Ontario, Canada, M5S 3A3
        • Sleep and Alertness Center
    • Quebec
      • Montreal, Quebec, Canada, QC H4A
        • McGill University Health Centre
  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35406
        • Alabama Neurology & Sleep Medicine
    • Arizona
      • Mesa, Arizona, United States, 85213
        • Desert Clinical Research - CCT Research
      • Phoenix, Arizona, United States, 85044
        • Foothills Research Center - CCT Research
      • Tempe, Arizona, United States, 85283
        • Fiel Family Sports Medicine - PC CCT Research
      • Tucson, Arizona, United States, 85704
        • Noble Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners, Inc.
    • California
      • Anaheim, California, United States, 92801
        • Orange County Research Institute
      • Carlsbad, California, United States, 92011
        • North County Neurology Associates
      • Cerritos, California, United States, 90703
        • Core Healthcare Group
      • Chula Vista, California, United States, 91910
        • Exalt Clinical Research
      • Montclair, California, United States, 91763
        • Catalina Research Institute
      • Riverside, California, United States, 92501
        • Probe Clinical Research Corporation
      • San Diego, California, United States, 92103
        • Pacific Research Network
      • San Ramon, California, United States, 94583
        • Sleep Medicine Specialists of California
      • Santa Ana, California, United States, 92705
        • SDS Clinical Trials Inc.
      • West Covina, California, United States, 91790
        • Provideré Research Inc.
    • Florida
      • Brandon, Florida, United States, 33511
        • Meris Clinical Research
      • Cutler Bay, Florida, United States, 33189
        • Nouvelle Clinical Research
      • DeLand, Florida, United States, 32720
        • Accel Research Sites
      • Hollywood, Florida, United States, 33024
        • Research Centers of America, LLC
      • Lake Worth, Florida, United States, 33467
        • Canvas Clinical Research
      • Lehigh Acres, Florida, United States, 33971
        • Florida Lung and Sleep Associates
      • Miami, Florida, United States, 33174
        • Advanced Medical Research Institute
      • Miami, Florida, United States, 33186
        • Clinical Site Partners
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc - Orlando
      • Tampa, Florida, United States, 33634
        • JSV Clinical Research Study Inc
      • Winter Park, Florida, United States, 32789
        • Florida Pediatric Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • NeuroTrials Research
      • Atlanta, Georgia, United States, 30031
        • Atlanta Center for Medical Research, LLC
      • Suwanee, Georgia, United States, 30024
        • Georgia Neurology and Sleep Medicine Assoc
      • Thomasville, Georgia, United States, 31792
        • Javarra Inc-Privia Medical Group
    • Idaho
      • Meridian, Idaho, United States, 83642
        • St. Lukes Clinic - Idaho Pulmonary Associates
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Chicago Research Center Inc
      • Peoria, Illinois, United States, 61637
        • OSF HealthCare Saint Francis Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40220
        • Advanced ENT and Allergy
    • Maryland
      • Elkridge, Maryland, United States, 21075
        • Centennial Medical Group
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Infinity Medical Research
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Lathrup Village, Michigan, United States, 48076
        • Revive Research Institute
    • Nevada
      • North Las Vegas, Nevada, United States, 89030
        • Las Vegas Clinical Trials
    • New Jersey
      • West Long Branch, New Jersey, United States, 07764
        • Neurology Specialists of Monmouth County
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Javara Inc - Tryon Medical Partners PLCC
      • Denver, North Carolina, United States, 28025
        • Research Carolina Elite
      • High Point, North Carolina, United States, 27260
        • Peters Medical Research, LLC
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • CTI Clinical Research Center
      • Cincinnati, Ohio, United States, 45245
        • Sleep Management Institute (Intrepid)
      • Cincinnati, Ohio, United States, 45267
        • UC Health Sleep Medicine
      • Cleveland, Ohio, United States, 44106
        • University Hospital of Cleveland Medical Center
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Neurological Associate
      • Wyomissing, Pennsylvania, United States, 19610
        • Respiratory Specialists
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research LL
      • Rock Hill, South Carolina, United States, 29732
        • OnSite Clinical Solutions LLC/Carolina Cardiology Associates P.A
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Research & Medicine, PLLC
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas, LP
      • Houston, Texas, United States, 77008
        • The Heights Hospital (HD Heights)
      • Houston, Texas, United States, 77030
        • Weill Cornell Medical College
      • Houston, Texas, United States, 77070
        • Lone Star Lung and Sleep Clinic
      • Huntsville, Texas, United States, 77340
        • Huntsville Research Institute LLC
      • Red Oak, Texas, United States, 75154
        • Epic Medical Research
      • San Antonio, Texas, United States, 78229
        • Element Research Group
    • Utah
      • South Ogden, Utah, United States, 84405
        • South Ogden Family Medicine / CCT Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥18 years of age at the time of informed consent.
  2. PSG criteria: AHI of ≥10 and ≤45; ≤ 25% central or mixed apneas; and PLM arousal index ≤15
  3. PROMIS-Fatigue: raw score ≥17
  4. PAP intolerance or current PAP refusal.
  5. BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive.

Exclusion Criteria:

  1. Narcolepsy, restless leg syndrome, REM sleep behavior disorder
  2. Insomnia disorder characterized by difficulty initiating or maintaining sleep, or use within the past month of sedative-hypnotics or other medication for the purpose of treating or avoiding insomnia symptoms.
  3. Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.
  4. Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed.
  5. Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral administration at bedtime
Experimental: AD109
Drug: AD109
Oral administration at bedtime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Apnea-Hypopnea Index (AHI)
Time Frame: 6 months
AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO2) by at least 4%.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apnimed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2023

Primary Completion (Actual)

March 10, 2025

Study Completion (Actual)

March 14, 2025

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APC-APN-305

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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