Clinical trial NCT05813275: Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: OSA
Keywords: Obstructive Sleep Apnea
Lead sponsor: Apnimed
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 646
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Efficacy of AD109 on airway obstruction in mild to sever OSA
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Alabama Neurology &amp; Sleep Medicine
state: Alabama
city: Mesa
country: United States
facility: Desert Clinical Research - 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 Sports Medicine - PC 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: Carlsbad
country: United States
facility: North County Neurology Associates
state: California
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
city: Chula Vista
country: United States
facility: Exalt Clinical Research
state: California
city: Montclair
country: United States
facility: Catalina Research Institute
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: Sleep Medicine Specialists of California
state: California
city: Santa Ana
country: United States
facility: SDS Clinical Trials Inc.
state: California
city: West Covina
country: United States
facility: Provideré Research Inc.
state: California
city: Brandon
country: United States
facility: Meris Clinical Research
state: Florida
city: Cutler Bay
country: United States
facility: Nouvelle Clinical Research
state: Florida
city: DeLand
country: United States
facility: Accel Research Sites
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America, LLC
state: Florida
city: Lake Worth
country: United States
facility: Canvas Clinical Research
state: Florida
city: Lehigh Acres
country: United States
facility: Florida Lung and Sleep Associates
state: Florida
city: Miami
country: United States
facility: Advanced Medical Research Institute
state: Florida
city: Miami
country: United States
facility: Clinical Site Partners
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc - Orlando
state: Florida
city: Tampa
country: United States
facility: JSV Clinical Research Study Inc
state: Florida
city: Winter Park
country: United States
facility: Florida Pediatric Research Institute
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research, LLC
state: Georgia
city: Atlanta
country: United States
facility: NeuroTrials Research
state: Georgia
city: Suwanee
country: United States
facility: Georgia Neurology and Sleep Medicine Assoc
state: Georgia
city: Thomasville
country: United States
facility: Javarra Inc-Privia Medical Group
state: Georgia
city: Meridian
country: United States
facility: St. Lukes Clinic - Idaho Pulmonary Associates
state: Idaho
city: Chicago
country: United States
facility: Chicago Research Center Inc
state: Illinois
city: Peoria
country: United States
facility: OSF HealthCare Saint Francis Medical Center
state: Illinois
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: North Dartmouth
country: United States
facility: Infinity Medical Research
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Lathrup Village
country: United States
facility: Revive Research Institute
state: Michigan
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: West Long Branch
country: United States
facility: Neurology Specialists of Monmouth County
state: New Jersey
city: Charlotte
country: United States
facility: Javara Inc - Tryon Medical Partners PLCC
state: North Carolina
city: Denver
country: United States
facility: Research Carolina Elite
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Sleep Management Institute (Intrepid)
state: Ohio
city: Cincinnati
country: United States
facility: UC Health Sleep Medicine
state: Ohio
city: Cleveland
country: United States
facility: University Hospital of Cleveland Medical Center
state: Ohio
city: Abington
country: United States
facility: Abington Neurological Associate
state: Pennsylvania
city: Wyomissing
country: United States
facility: Respiratory Specialists
state: Pennsylvania
city: Greenville
country: United States
facility: Tribe Clinical Research LL
state: South Carolina
city: Rock Hill
country: United States
facility: OnSite Clinical Solutions LLC/Carolina Cardiology Associates P.A
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Research &amp; Medicine, PLLC
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Houston
country: United States
facility: The Heights Hospital (HD Heights)
state: Texas
city: Houston
country: United States
facility: Weill Cornell Medical College
state: Texas
city: Houston
country: United States
facility: Lone Star Lung and Sleep Clinic
state: Texas
city: Huntsville
country: United States
facility: Huntsville Research Institute LLC
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research
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: Calgary
country: Canada
facility: Canadian Sleep Consultants
state: Alberta
city: Kelowna
country: Canada
facility: Medical Arts Health Research
state: British Columbia
city: Markham
country: Canada
facility: AMNDX
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: Toronto Sleep Institute
state: Ontario
city: Toronto
country: Canada
facility: Sleep and Alertness Center
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References: