Continuation Protocol for Obstructive Sleep Apnea (OSA)

Recruitment Status
ENROLLING BY INVITATION
(See Contacts and Locations)Verified April 2025 by Apnimed
Sponsor
Apnimed
Information Provided by (Responsible Party)
Apnimed
Clinicaltrials.gov Identifier
NCT06566820
Other Study ID Numbers:
APC-APN-306
First Submitted
July 2, 2024
First Posted
August 21, 2024
Last Update Posted
May 12, 2025
Last Verified
April 2025

ClinicalTrials.gov processed this data on May 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
OSA
Drug: Aroxybutynin and Atomoxetine

Study Design

Study TypeInterventional
Actual Enrollment1280 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeOther
Official TitleA Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea
Study Start DateJuly 2, 2024
Actual Primary Completion Date1mo 1w from now
Actual Study Completion Date1mo 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
AD109
Open Label AD109
Drug: Aroxybutynin and Atomoxetine
Fixed Dose Combination

Outcome Measures

Primary Outcome Measures
  1. 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.
  2. 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.
  3. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Inclusion Criteria
Completion of APC-APN-304 without permanent discontinuation of IMP.
Completion of APC-APN-305 without permanent discontinuation of IMP.
Exclusion Criteria
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.

Contacts and Locations

Sponsors and CollaboratorsApnimed
Locations
Sleep Disorders Center of America | Birmingham Alabama, United States, 35213The University of Alabama/Institute for Rural Health Research | Tuscaloosa Alabama, United States, 35401Chandler Clinical Trials | Chandler Arizona, United States, 85224Desert Clinical Reserach, LLC/CCT Research | Mesa Arizona, United States, 85213Foothills Research Center/CCT Research | Phoenix Arizona, United States, 85044Fiel Family and Sports Medicine/CCT Research | Tempe Arizona, United States, 85283Noble Clinical Research | Tucson Arizona, United States, 85704Preferred Research Partners, Inc. | Little Rock Arkansas, United States, 72211Orange County Research Institute | Anaheim California, United States, 92801Core Healthcare Group | Cerritos California, United States, 90703Exalt Clinical Research, Inc. | Chula Vista California, United States, 91910Collaborative Neuroscience Research, LLC | Los Alamitos California, United States, 90720Santa Monica Clinical Trials | Los Angeles California, United States, 90025Empire Clinical Research | Pomona California, United States, 91767Probe Clinical Research Corporation | Riverside California, United States, 92501Pacific Research Network | San Diego California, United States, 92103TriValley Sleep Center | San Ramon California, United States, 94583SDS Clinical Trials, Inc. | Santa Ana California, United States, 92705Providere Research Inc. | West Covina California, United States, 91790Mountain View Clinical Research, Inc. | Denver Colorado, United States, 80209Meris Clinical Research | Brandon Florida, United States, 33511Teradan Clinical Trials | Brandon Florida, United States, 33511St. Francis Medical Institute | Clearwater Florida, United States, 33765Nouvelle Clinical Research | Cutler Bay Florida, United States, 33189Arrow Clinical Trials | Daytona Beach Florida, United States, 32117Canvas Clinical Research | Lake Worth Florida, United States, 33467Florida Lung & Sleep Associates | Lehigh Acres Florida, United States, 33971Ivetmar Medical Group, LLC | Miami Florida, United States, 33155Advanced Medical Research Institute | Miami Florida, United States, 33174PharmaDev Clinical Research Institute, LLC | Miami Florida, United States, 33176Flourish Research | Miami Florida, United States, 33186Renstar Medical Research | Ocala Florida, United States, 34470Clinical Neuroscience Solutions, Inc. | Orlando Florida, United States, 32801JSV Clinical Research Study Inc. | Tampa Florida, United States, 33634Palm Beach Research Center | West Palm Beach Florida, United States, 33409Central Florida Pediatric Sleep Disorders d/b/a Florida Pediatric Institute, LLC | Winter Park Florida, United States, 32789Clinical Site Partners, LLC dba Flourish Research | Winter Park Florida, United States, 32789Neurotrials Research Inc | Atlanta Georgia, United States, 30328Atlanta Center for Medical Research | Atlanta Georgia, United States, 30331CenExel iResearch, LLC | Decatur Georgia, United States, 30030Georgia Neurology and Sleep Medicine Associates | Suwanee Georgia, United States, 30024Medster Research | Valdosta Georgia, United States, 31605St. Luke's Idaho Pulmonary Associates - Meridian Clinic | Meridian Idaho, United States, 83642Chicago Research Center, Inc. | Chicago Illinois, United States, 60634University of Kansas Medical Center | Kansas City Kansas, United States, 66160Advanced ENT and Allergy | Louisville Kentucky, United States, 40220Centennial Medical Group Research Department | Columbia Maryland, United States, 21045Sleep Disorders Centers of the Mid-Atlantic | Glen Burnie Maryland, United States, 21061Velocity Clinical Research | Rockville Maryland, United States, 20854Neurocare, Inc. | Newton Massachusetts, United States, 02459Infinity Medical Research | North Dartmouth Massachusetts, United States, 02747Baystate Clinical Trials Unit | Springfield Massachusetts, United States, 01107University of Michigan Clinical Research Unit | Ann Arbor Michigan, United States, 48109Revive Research Institute, Inc. | Lathrup Village Michigan, United States, 48076Henry Ford Medical Center - Columbus | Novi Michigan, United States, 48377Clinical Neurophysiology Services PC | Sterling Heights Michigan, United States, 48314Sleep Medicine and Research Center, St. Luke's Hospital | Chesterfield Missouri, United States, 63017Healthcare Research Network | Hazelwood Missouri, United States, 63042Clayton Sleep Institute, LLC | St Louis Missouri, United States, 63123Henderson Clinical Trials | Henderson Nevada, United States, 89052Las Vegas Clinical Trials, LLC | North Las Vegas Nevada, United States, 89030Clinilabs Drug Development Corporation | Eatontown New Jersey, United States, 07724Sleep Dynamics | Neptune City New Jersey, United States, 07753Maimonides Sleep Arts & Sciences | Albuquerque New Mexico, United States, 87107Northwell Health | New Hyde Park New York, United States, 11042Research Carolina Elite | Denver North Carolina, United States, 28037Clinical Research of Gastonia | Gastonia North Carolina, United States, 28054Peters Medical Research LLC | High Point North Carolina, United States, 27260Advanced Respiratory and Sleep Medicine | Huntersville North Carolina, United States, 28078Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine | New Bern North Carolina, United States, 28562Accellacare | Wilmington North Carolina, United States, 28412Lillestol Research | Fargo North Dakota, United States, 58104NeuroScience Research Center, LLC | Canton Ohio, United States, 44718CTI Clinical Research Center | Cincinnati Ohio, United States, 45212Intrepid Research, LLC | Cincinnati Ohio, United States, 45245Northwest Research Center | Portland Oregon, United States, 97202Abington Neurological Associates | Abington Pennsylvania, United States, 19001Respiratory Specialists | Wyomissing Pennsylvania, United States, 19610Lowcountry Lung and Critical Care, PA | Charleston South Carolina, United States, 29406Tribe Clinical Research, LLC | Greenville South Carolina, United States, 29607Velocity Clinical Research, Greenville | Greenville South Carolina, United States, 29615OnSite Clinical Solutions, LLC | Rock Hill South Carolina, United States, 29732Chattanooga Research & Medicine | Chattanooga Tennessee, United States, 37404Clinical Neuroscience Solutions, Inc. | Memphis Tennessee, United States, 38119FutureSearch Trials of Neurology | Austin Texas, United States, 78731FutureSearch Trials of Dallas | Dallas Texas, United States, 75231Memorial Hermann Village | Houston Texas, United States, 77043Houston Clinical Research Associates | Houston Texas, United States, 77070Huntsville Research Institute | Huntsville Texas, United States, 77340Sleep Therapy and Research Center | San Antonio Texas, United States, 78229Element Research Group | San Antonio Texas, United States, 78258South Ogden Family Medicine/CCT Research | South Ogden Utah, United States, 84405Sleep Disorder Center of the Mid-Atlantic | Vienna Virginia, United States, 22182Medical Arts Health Research Group | Kelowna British Columbia, Canada, VIY 4N7AMNDX Inc | Markham Ontario, Canada, L3R 1A3West Ottawa Sleep Centre | Ottawa Ontario, Canada, K2C 0P7Canadian Phase Onward Inc. | Toronto Ontario, Canada, M3J 0K2Jodha Tishon, Inc. | Toronto Ontario, Canada, M5S 3A3McGill University Health Centre | Montreal Quebec, Canada, H4A 3J1
Investigators
Study Director: Ron Farkas, MD, Apnimed