Continuation Protocol for Obstructive Sleep Apnea (OSA)
A Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea
1 other identifier
interventional
1,280
2 countries
99
Brief Summary
The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA). The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2024
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2024
CompletedStudy Start
First participant enrolled
July 3, 2024
CompletedFirst Posted
Study publicly available on registry
August 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
May 13, 2025
May 1, 2025
2 years
July 3, 2024
May 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. An SAE was an AE during any study phase that fulfills one or more of the following criteria: results in death, life threatening (The term 'life-threatening' in the definition of 'serious' refers to an event in which the participant was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity.
through study completion, an average of 1 year
Number of Participants With Vital Signs Abnormalities
Vital signs that are planned to be assessed include parameters such as weight,heart rate and systolic and diastolic blood pressure.
through study completion, an average of 1 year
Number of Participants With Concomitant Therapy (Medication or Devices)
Concomitant therapy with devices (i.e., CPAP) and concomitant medications are other prescription medications, over-the-counter (OTC) drugs or dietary supplements that a study participant takes in addition to the drug under investigation.
through study completion, an average of 1 year
Study Arms (1)
AD109
EXPERIMENTALOpen Label AD109
Interventions
Eligibility Criteria
You may qualify if:
- Completion of APC-APN-304 without permanent discontinuation of IMP.
- Completion of APC-APN-305 without permanent discontinuation of IMP.
You may not qualify if:
- Participants are excluded from the study if participation would be considered unsafe by the investigator based on the individual's current status.
- Participants are excluded from the study if participation would be considered unsafe by the investigator based on concomitant therapies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Apnimedlead
Study Sites (99)
Sleep Disorders Center of America
Birmingham, Alabama, 35213, United States
The University of Alabama/Institute for Rural Health Research
Tuscaloosa, Alabama, 35401, United States
Chandler Clinical Trials
Chandler, Arizona, 85224, United States
Desert Clinical Reserach, LLC/CCT Research
Mesa, Arizona, 85213, United States
Foothills Research Center/CCT Research
Phoenix, Arizona, 85044, United States
Fiel Family and Sports Medicine/CCT Research
Tempe, Arizona, 85283, United States
Noble Clinical Research
Tucson, Arizona, 85704, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211, United States
Orange County Research Institute
Anaheim, California, 92801, United States
Core Healthcare Group
Cerritos, California, 90703, United States
Exalt Clinical Research, Inc.
Chula Vista, California, 91910, United States
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720, United States
Santa Monica Clinical Trials
Los Angeles, California, 90025, United States
Empire Clinical Research
Pomona, California, 91767, United States
Probe Clinical Research Corporation
Riverside, California, 92501, United States
Pacific Research Network
San Diego, California, 92103, United States
TriValley Sleep Center
San Ramon, California, 94583, United States
SDS Clinical Trials, Inc.
Santa Ana, California, 92705, United States
Providere Research Inc.
West Covina, California, 91790, United States
Mountain View Clinical Research, Inc.
Denver, Colorado, 80209, United States
Meris Clinical Research
Brandon, Florida, 33511, United States
Teradan Clinical Trials
Brandon, Florida, 33511, United States
St. Francis Medical Institute
Clearwater, Florida, 33765, United States
Nouvelle Clinical Research
Cutler Bay, Florida, 33189, United States
Arrow Clinical Trials
Daytona Beach, Florida, 32117, United States
Canvas Clinical Research
Lake Worth, Florida, 33467, United States
Florida Lung & Sleep Associates
Lehigh Acres, Florida, 33971, United States
Ivetmar Medical Group, LLC
Miami, Florida, 33155, United States
Advanced Medical Research Institute
Miami, Florida, 33174, United States
PharmaDev Clinical Research Institute, LLC
Miami, Florida, 33176, United States
Flourish Research
Miami, Florida, 33186, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
JSV Clinical Research Study Inc.
Tampa, Florida, 33634, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Central Florida Pediatric Sleep Disorders d/b/a Florida Pediatric Institute, LLC
Winter Park, Florida, 32789, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789, United States
Neurotrials Research Inc
Atlanta, Georgia, 30328, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
Georgia Neurology and Sleep Medicine Associates
Suwanee, Georgia, 30024, United States
Medster Research
Valdosta, Georgia, 31605, United States
St. Luke's Idaho Pulmonary Associates - Meridian Clinic
Meridian, Idaho, 83642, United States
Chicago Research Center, Inc.
Chicago, Illinois, 60634, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Advanced ENT and Allergy
Louisville, Kentucky, 40220, United States
Centennial Medical Group Research Department
Columbia, Maryland, 21045, United States
Sleep Disorders Centers of the Mid-Atlantic
Glen Burnie, Maryland, 21061, United States
Velocity Clinical Research
Rockville, Maryland, 20854, United States
Neurocare, Inc.
Newton, Massachusetts, 02459, United States
Infinity Medical Research
North Dartmouth, Massachusetts, 02747, United States
Baystate Clinical Trials Unit
Springfield, Massachusetts, 01107, United States
University of Michigan Clinical Research Unit
Ann Arbor, Michigan, 48109, United States
Revive Research Institute, Inc.
Lathrup Village, Michigan, 48076, United States
Henry Ford Medical Center - Columbus
Novi, Michigan, 48377, United States
Clinical Neurophysiology Services PC
Sterling Heights, Michigan, 48314, United States
Sleep Medicine and Research Center, St. Luke's Hospital
Chesterfield, Missouri, 63017, United States
Healthcare Research Network
Hazelwood, Missouri, 63042, United States
Clayton Sleep Institute, LLC
St Louis, Missouri, 63123, United States
Henderson Clinical Trials
Henderson, Nevada, 89052, United States
Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, 89030, United States
Clinilabs Drug Development Corporation
Eatontown, New Jersey, 07724, United States
Sleep Dynamics
Neptune City, New Jersey, 07753, United States
Maimonides Sleep Arts & Sciences
Albuquerque, New Mexico, 87107, United States
Northwell Health
New Hyde Park, New York, 11042, United States
Research Carolina Elite
Denver, North Carolina, 28037, United States
Clinical Research of Gastonia
Gastonia, North Carolina, 28054, United States
Peters Medical Research LLC
High Point, North Carolina, 27260, United States
Advanced Respiratory and Sleep Medicine
Huntersville, North Carolina, 28078, United States
Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
New Bern, North Carolina, 28562, United States
Accellacare
Wilmington, North Carolina, 28412, United States
Lillestol Research
Fargo, North Dakota, 58104, United States
NeuroScience Research Center, LLC
Canton, Ohio, 44718, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Intrepid Research, LLC
Cincinnati, Ohio, 45245, United States
Northwest Research Center
Portland, Oregon, 97202, United States
Abington Neurological Associates
Abington, Pennsylvania, 19001, United States
Respiratory Specialists
Wyomissing, Pennsylvania, 19610, United States
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina, 29406, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Velocity Clinical Research, Greenville
Greenville, South Carolina, 29615, United States
OnSite Clinical Solutions, LLC
Rock Hill, South Carolina, 29732, United States
Chattanooga Research & Medicine
Chattanooga, Tennessee, 37404, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75231, United States
Memorial Hermann Village
Houston, Texas, 77043, United States
Houston Clinical Research Associates
Houston, Texas, 77070, United States
Huntsville Research Institute
Huntsville, Texas, 77340, United States
Sleep Therapy and Research Center
San Antonio, Texas, 78229, United States
Element Research Group
San Antonio, Texas, 78258, United States
South Ogden Family Medicine/CCT Research
South Ogden, Utah, 84405, United States
Sleep Disorder Center of the Mid-Atlantic
Vienna, Virginia, 22182, United States
Medical Arts Health Research Group
Kelowna, British Columbia, VIY 4N7, Canada
AMNDX Inc
Markham, Ontario, L3R 1A3, Canada
West Ottawa Sleep Centre
Ottawa, Ontario, K2C 0P7, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 0K2, Canada
Jodha Tishon, Inc.
Toronto, Ontario, M5S 3A3, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ron Farkas, MD
Apnimed
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2024
First Posted
August 22, 2024
Study Start
July 3, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share