OSA Clinical Trial
Official title:
Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (LunAIRo Study)
| Verified date | September 2023 |
| Source | Apnimed |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
| Status | Active, not recruiting |
| Enrollment | 660 |
| Est. completion date | June 2025 |
| Est. primary completion date | June 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Maimonides Sleep Arts and Sciences | Albuquerque | New Mexico |
| United States | Orange County Research Institute | Anaheim | California |
| United States | NeuroTrials Research | Atlanta | Georgia |
| United States | FutureSearch Trials of Neurology | Austin | Texas |
| United States | Sleep Disorders Center of Alabama | Birmingham | Alabama |
| United States | Alpine Clinical Research Center | Boulder | Colorado |
| United States | Teradan Clinical trials LLC | Brandon | Florida |
| United States | NeuroScience Research Center, LLC | Canton | Ohio |
| United States | Chandler Clinical Trials | Chandler | Arizona |
| United States | Lowcountry Lung and Critical Care | Charleston | South Carolina |
| United States | St Lukes Hospital | Chesterfield | Missouri |
| United States | Chicago Research Center Inc | Chicago | Illinois |
| United States | CTI Clinical Research Center | Cincinnati | Ohio |
| United States | Sleep Management Institute | Cincinnati | Ohio |
| United States | St. Francis Medical Institute | Clearwater | Florida |
| United States | Nouvelle Clinical Research | Cutler Bay | Florida |
| United States | Arrow Clinical Trials | Daytona Beach | Florida |
| United States | CenExel iResearch | Decatur | Georgia |
| United States | Mountain View Clinical Research, Inc. | Denver | Colorado |
| United States | Research Carolina Elite | Denver | North Carolina |
| United States | Ohio Sleep Medicine Institute | Dublin | Ohio |
| United States | Clinilabs, Inc | Eatontown | New Jersey |
| United States | Clinical Research of Gastonia | Gastonia | North Carolina |
| United States | Sleep Disorders Centers of the Mid-Atlantic | Glen Burnie | Maryland |
| United States | Velocity Clinical Research - Greenville | Greenville | South Carolina |
| United States | Healthcare Research Network | Hazelwood | Missouri |
| United States | Henderson Clinical Trials | Henderson | Nevada |
| United States | Cenexel Research Centers of America - Hollywood | Hollywood | Florida |
| United States | Advanced Respiratory and Sleep Medicine, LLC | Huntersville | North Carolina |
| United States | Marvel Clinical Research, LLC | Huntington Beach | California |
| United States | Western Michigan University Homer Stryker M.D. School of Medicine | Kalamazoo | Michigan |
| United States | Preferred Research Partners, Inc. | Little Rock | Arkansas |
| United States | CenExel CNS | Los Alamitos | California |
| United States | Santa Monica Clinical Trials | Los Angeles | California |
| United States | Sleep Practitioners, LLC | Macon | Georgia |
| United States | Brian Abaluck, LLC | Malvern | Pennsylvania |
| United States | Clinical Neuroscience Solutions - Memphis | Memphis | Tennessee |
| United States | Ivetmar Medical Group LLC | Miami | Florida |
| United States | PharmaDev Clinical Research Institute, LLC | Miami | Florida |
| United States | Coastal Carolina Health Care | New Bern | North Carolina |
| United States | Northwell Health Physician Partners | New Hyde Park | New York |
| United States | Neurocare, Inc | Newton | Massachusetts |
| United States | Infinity Medical Research | North Dartmouth | Massachusetts |
| United States | Great Plains Health | North Platte | Nebraska |
| United States | Nuvance Health | Norwalk | Connecticut |
| United States | Henry Ford Health (Sleep Research Department) | Novi | Michigan |
| United States | Renstar Medical Research | Ocala | Florida |
| United States | UPMC Comprehensive Lung Center - Sleep Medicine | Pittsburgh | Pennsylvania |
| United States | Empire Clinical Research | Pomona | California |
| United States | Northwest Research Center | Portland | Oregon |
| United States | Meridian Clinical Research | Raleigh | North Carolina |
| United States | Centricity Research Rincon Pulmonology | Rincon | Georgia |
| United States | Velocity Clinical Research | Rockville | Maryland |
| United States | Central Texas Neurology Consultants, PA | Round Rock | Texas |
| United States | Clayton Sleep Institute | Saint Louis | Missouri |
| United States | Sleep Therapy Research Center | San Antonio | Texas |
| United States | Pacific Research Network | San Diego | California |
| United States | SDS Clinical Trials Inc. | Santa Ana | California |
| United States | Baystate Medical Center (BMC) - Baystate Sleep Medicine | Springfield | Massachusetts |
| United States | Clinical Neurophysiology Services | Sterling Heights | Michigan |
| United States | Medster Research | Valdosta | Georgia |
| United States | Sleep Disorders Centers of the Mid-Atlantic | Vienna | Virginia |
| United States | Palm Beach Research ClinEdge-PPDS | West Palm Beach | Florida |
| United States | Clinical Site Partners, LLC dba Flourish Research | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Apnimed |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy of AD109 on airway obstruction in mild to severe 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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