Clinical trial NCT06566820: Continuation Protocol for Obstructive Sleep Apnea (OSA)
Official title: A Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: OSA
Keywords: Obstructive Sleep Apnea
Lead sponsor: Apnimed
Sponsor class: INDUSTRY
First posted: 2024-08-22
Enrollment: 1280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs)
timeFrame: through study completion, an average of 1 year
measure: Number of Participants With Vital Signs Abnormalities
timeFrame: through study completion, an average of 1 year
measure: Number of Participants With Concomitant Therapy (Medication or Devices)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of America
state: Alabama
city: Tuscaloosa
country: United States
facility: The University of Alabama/Institute for Rural Health Research
state: Alabama
city: Chandler
country: United States
facility: Chandler Clinical Trials
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Reserach, LLC/CCT Research
state: Arizona
city: Phoenix
country: United States
facility: Foothills Research Center/CCT Research
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine/CCT Research
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc.
state: Arkansas
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
city: Chula Vista
country: United States
facility: Exalt Clinical Research, Inc.
state: California
city: Los Alamitos
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Los Angeles
country: United States
facility: Santa Monica Clinical Trials
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: Riverside
country: United States
facility: Probe Clinical Research Corporation
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: San Ramon
country: United States
facility: TriValley Sleep Center
state: California
city: Santa Ana
country: United States
facility: SDS Clinical Trials, Inc.
state: California
city: West Covina
country: United States
facility: Providere Research Inc.
state: California
city: Denver
country: United States
facility: Mountain View Clinical Research, Inc.
state: Colorado
city: Brandon
country: United States
facility: Meris Clinical Research
state: Florida
city: Brandon
country: United States
facility: Teradan Clinical Trials
state: Florida
city: Clearwater
country: United States
facility: St. Francis Medical Institute
state: Florida
city: Cutler Bay
country: United States
facility: Nouvelle Clinical Research
state: Florida
city: Daytona Beach
country: United States
facility: Arrow Clinical Trials
state: Florida
city: Lake Worth
country: United States
facility: Canvas Clinical Research
state: Florida
city: Lehigh Acres
country: United States
facility: Florida Lung & Sleep Associates
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group, LLC
state: Florida
city: Miami
country: United States
facility: Advanced Medical Research Institute
state: Florida
city: Miami
country: United States
facility: PharmaDev Clinical Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Flourish Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Tampa
country: United States
facility: JSV Clinical Research Study Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Winter Park
country: United States
facility: Central Florida Pediatric Sleep Disorders d/b/a Florida Pediatric Institute, LLC
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC dba Flourish Research
state: Florida
city: Atlanta
country: United States
facility: Neurotrials Research Inc
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Suwanee
country: United States
facility: Georgia Neurology and Sleep Medicine Associates
state: Georgia
city: Valdosta
country: United States
facility: Medster Research
state: Georgia
city: Meridian
country: United States
facility: St. Luke's Idaho Pulmonary Associates - Meridian Clinic
state: Idaho
city: Chicago
country: United States
facility: Chicago Research Center, Inc.
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: Columbia
country: United States
facility: Centennial Medical Group Research Department
state: Maryland
city: Glen Burnie
country: United States
facility: Sleep Disorders Centers of the Mid-Atlantic
state: Maryland
city: Rockville
country: United States
facility: Velocity Clinical Research
state: Maryland
city: Newton
country: United States
facility: Neurocare, Inc.
state: Massachusetts
city: North Dartmouth
country: United States
facility: Infinity Medical Research
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Clinical Trials Unit
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Clinical Research Unit
state: Michigan
city: Lathrup Village
country: United States
facility: Revive Research Institute, Inc.
state: Michigan
city: Novi
country: United States
facility: Henry Ford Medical Center - Columbus
state: Michigan
city: Sterling Heights
country: United States
facility: Clinical Neurophysiology Services PC
state: Michigan
city: Chesterfield
country: United States
facility: Sleep Medicine and Research Center, St. Luke's Hospital
state: Missouri
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: St. Louis
country: United States
facility: Clayton Sleep Institute, LLC
state: Missouri
city: Henderson
country: United States
facility: Henderson Clinical Trials
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials, LLC
state: Nevada
city: Eatontown
country: United States
facility: Clinilabs Drug Development Corporation
state: New Jersey
city: Neptune
country: United States
facility: Sleep Dynamics
state: New Jersey
city: Albuquerque
country: United States
facility: Maimonides Sleep Arts & Sciences
state: New Mexico
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Denver
country: United States
facility: Research Carolina Elite
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research LLC
state: North Carolina
city: Huntersville
country: United States
facility: Advanced Respiratory and Sleep Medicine
state: North Carolina
city: New Bern
country: United States
facility: Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Canton
country: United States
facility: NeuroScience Research Center, LLC
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Intrepid Research, LLC
state: Ohio
city: Portland
country: United States
facility: Northwest Research Center
state: Oregon
city: Abington
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Wyomissing
country: United States
facility: Respiratory Specialists
state: Pennsylvania
city: Charleston
country: United States
facility: Lowcountry Lung and Critical Care, PA
state: South Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Greenville
country: United States
facility: Velocity Clinical Research, Greenville
state: South Carolina
city: Rock Hill
country: United States
facility: OnSite Clinical Solutions, LLC
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Research & Medicine
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Village
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Associates
state: Texas
city: Huntsville
country: United States
facility: Huntsville Research Institute
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy and Research Center
state: Texas
city: San Antonio
country: United States
facility: Element Research Group
state: Texas
city: South Ogden
country: United States
facility: South Ogden Family Medicine/CCT Research
state: Utah
city: Vienna
country: United States
facility: Sleep Disorder Center of the Mid-Atlantic
state: Virginia
city: Kelowna
country: Canada
facility: Medical Arts Health Research Group
state: British Columbia
city: Markham
country: Canada
facility: AMNDX Inc
state: Ontario
city: Ottawa
country: Canada
facility: West Ottawa Sleep Centre
state: Ontario
city: Toronto
country: Canada
facility: Canadian Phase Onward Inc.
state: Ontario
city: Toronto
country: Canada
facility: Jodha Tishon, Inc.
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Apnimed
name: Ron Farkas, MD
role: STUDY_DIRECTOR
References: