OSA Clinical Trial
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)
| Verified date | April 2024 |
| Source | Apnimed |
| Contact | Ron Farkis, MD |
| Phone | 6175008880 |
| Info[@]apnimed.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 640 |
| Est. completion date | February 2025 |
| Est. primary completion date | February 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. =18 years of age at the time of informed consent. 2. PSG criteria: AHI of >5; = 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: - |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Canadian Sleep Consultants | Calgary | Alberta |
| Canada | Medical Arts Health Research | Kelowna | British Columbia |
| Canada | AMNDX | Markham | Ontario |
| Canada | West Ottawa Sleep Centre | Ottawa | Ontario |
| Canada | Canadian Phase Onward Inc. | Toronto | Ontario |
| Canada | Sleep and Alertness Center | Toronto | Ontario |
| Canada | Toronto Sleep Institute | Toronto | Ontario |
| United States | Abington Neurological Associate | Abington | Pennsylvania |
| United States | Orange County Research Institute | Anaheim | California |
| United States | Atlanta Center for Medical Research, LLC | Atlanta | Georgia |
| United States | FutureSearch Trials of Neurology | Austin | Texas |
| United States | North County Neurology Associates | Carlsbad | California |
| United States | Core Healthcare Group | Cerritos | California |
| United States | Javara Inc - Tryon Medical Partners PLCC | Charlotte | North Carolina |
| United States | Chattanooga Research & Medicine, PLLC | Chattanooga | Tennessee |
| United States | Chicago Research Center Inc | Chicago | Illinois |
| United States | Exalt Clinical Research | Chula Vista | California |
| United States | CTI Clinical Research Center | Cincinnati | Ohio |
| United States | Sleepp Management Institute (Intrepid) | Cincinnati | Ohio |
| United States | UC Health Sleep Medicine | Cincinnati | Ohio |
| United States | FutureSearch Trials of Dallas, LP | Dallas | Texas |
| United States | Accel Research Sites | DeLand | Florida |
| United States | Centennial Medical Group | Elkridge | Maryland |
| United States | Lillestol Research LLC | Fargo | North Dakota |
| United States | Tribe Clinical Research LL | Greenville | South Carolina |
| United States | Research Centers of America, LLC | Hollywood | Florida |
| United States | Lone Star Lung and Sleep Clinic | Houston | Texas |
| United States | The Heights Hospital (HD Heights) | Houston | Texas |
| United States | Huntsville Research Institute LLC | Huntsville | Texas |
| United States | The University of Kansas Medical Center | Kansas City | Kansas |
| United States | Canvas Clinical Research | Lake Worth | Florida |
| United States | Revive Research Institute | Lathrup Village | Michigan |
| United States | Florida Lung and Sleep Associates | Lehigh Acres | Florida |
| United States | Preferred Research Partners, Inc. | Little Rock | Arkansas |
| United States | Advanced ENT and Allergy | Louisville | Kentucky |
| United States | Desert Clinical Research - CCT Research | Mesa | Arizona |
| United States | Advanced Medical Research Institute | Miami | Florida |
| United States | Clinical Site Partners | Miami | Florida |
| United States | Catalina Research Institute | Montclair | California |
| United States | Las Vegas Clinical Trials | North Las Vegas | Nevada |
| United States | Clinical Neuroscience Solutions, Inc - Orlando | Orlando | Florida |
| United States | Foothills Research Center - CCT Research | Phoenix | Arizona |
| United States | Epic Medical Research | Red Oak | Texas |
| United States | Probe Clinical Research Corporation | Riverside | California |
| United States | OnSite Clinical Solutions LLC/Carolina Cardiology Associates P.A | Rock Hill | South Carolina |
| United States | Element Research Group | San Antonio | Texas |
| United States | Pacific Research Network | San Diego | California |
| United States | Sleep Medicine Specialists of California | San Ramon | California |
| United States | SDS Clinical Trials Inc. | Santa Ana | California |
| United States | South Ogden Family Medicine / CCT Research | South Ogden | Utah |
| United States | Georgia Neurology and Sleep Medicine Assoc | Suwanee | Georgia |
| United States | JSV Clinical Research Study Inc | Tampa | Florida |
| United States | Fiel Family Sports Medicine - PC CCT Research | Tempe | Arizona |
| United States | Javarra Inc-Privia Medical Group | Thomasville | Georgia |
| United States | Noble Clinical Research | Tucson | Arizona |
| United States | Alabama Neurology & Sleep Medicine | Tuscaloosa | Alabama |
| United States | Providere' Research Incorporated | West Covina | California |
| United States | Neurology Specialists of Monmouth County | West Long Branch | New Jersey |
| United States | PMG Research of Wilmington | Wilmington | North Carolina |
| United States | Florida Pediatric Research Institute | Winter Park | Florida |
| United States | Respiratory Specialists | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Apnimed |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy of AD109 on airway obstruction in mild to sever OSA | Proportion of participants with reduction in AHI (AHI, average number of events for every hour of sleep), measured by polysomnography | 6 months |
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