CompletedPhase 3
Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)
Key facts
- Where
- Albuquerque, Anaheim, Atlanta, Austin, Birmingham, Boulder, Brandon, Canton, Chandler, Charleston, Chesterfield, Chicago, Cincinnati, Clearwater, Cutler Bay, Daytona Beach, Decatur, Denver, Dublin, Eatontown, Gastonia, Glen Burnie, Greenville, Hazelwood, Henderson, Hollywood, Huntersville, Huntington Beach, Kalamazoo, Little Rock, Los Alamitos, Los Angeles, Macon, Malvern, Memphis, Miami, New Bern, New Hyde Park, Newton, North Dartmouth, North Platte, Norwalk, Novi, Ocala, Pittsburgh, Pomona, Portland, Raleigh, Rincon, Rockville, Round Rock, San Antonio, San Diego, Santa Ana, Springfield, St Louis, Sterling Heights, Valdosta, Vienna, West Palm Beach, and Winter Park, United StatesSee the 64 sites
- Phase
- Phase 3
Where in United States
- Maimonides Sleep Arts and SciencesAlbuquerque, United StatesNo longer taking part
- Orange County Research InstituteAnaheim, United StatesNo longer taking part
- NeuroTrials ResearchAtlanta, United StatesNo longer taking part
- FutureSearch Trials of NeurologyAustin, United StatesNo longer taking part
- Sleep Disorders Center of AlabamaBirmingham, United StatesNo longer taking part
- Alpine Clinical Research CenterBoulder, United StatesNo longer taking part
- Teradan Clinical trials LLCBrandon, United StatesNo longer taking part
- NeuroScience Research Center LLCCanton, United StatesNo longer taking part
- Chandler Clinical TrialsChandler, United StatesNo longer taking part
- Lowcountry Lung and Critical CareCharleston, United StatesNo longer taking part
- St Lukes HospitalChesterfield, United StatesNo longer taking part
- Chicago Research Center Inc.Chicago, United StatesNo longer taking part
- CTI Clinical Research CenterCincinnati, United StatesNo longer taking part
- Sleep Management InstituteCincinnati, United StatesNo longer taking part
- St Francis Medical InstituteClearwater, United StatesNo longer taking part
- Nouvelle Clinical ResearchCutler Bay, United StatesNo longer taking part
- Arrow Clinical TrialsDaytona Beach, United StatesNo longer taking part
- CenExel iResearchDecatur, United StatesNo longer taking part
- Mountain View Clinical Research, IncDenver, United StatesNo longer taking part
- Research Carolina EliteDenver, United StatesNo longer taking part
- Ohio Sleep Medicine InstituteDublin, United StatesNo longer taking part
- Clinilabs, IncEatontown, United StatesNo longer taking part
- Clinical Research of GastoniaGastonia, United StatesNo longer taking part
- Sleep Disorders Centers of the Mid-AtlanticGlen Burnie, United StatesNo longer taking part
- Velocity Clinical Research - GreenvilleGreenville, United StatesNo longer taking part
- Healthcare Research NetworkHazelwood, United StatesNo longer taking part
- Henderson Clinical TrialsHenderson, United StatesNo longer taking part
- Cenexel Research Centers of America - HollywoodHollywood, United StatesNo longer taking part
- Advanced Respiratory and Sleep Medicine LLCHuntersville, United StatesNo longer taking part
- Marvel Clinical Research, LLCHuntington Beach, United StatesNo longer taking part
- Western Michigan University Homer Stryker M.D. School of MedicineKalamazoo, United StatesNo longer taking part
- Preferred Research Partners, IncLittle Rock, United StatesNo longer taking part
- CenExel CNSLos Alamitos, United StatesNo longer taking part
- Santa Monica Clinical TrialsLos Angeles, United StatesNo longer taking part
- Sleep Practitioners, LLCMacon, United StatesNo longer taking part
- Brian Abaluck, LLCMalvern, United StatesNo longer taking part
- Clinical Neuroscience Solutions - MemphisMemphis, United StatesNo longer taking part
- Ivetmar Medical Group, LLCMiami, United StatesNo longer taking part
- PharmaDev Clinical Research Institute, LLCMiami, United StatesNo longer taking part
- Coastal Carolina Health CareNew Bern, United StatesNo longer taking part
- Northwell Health Physician PartnersNew Hyde Park, United StatesNo longer taking part
- Neurocare, Inc.Newton, United StatesNo longer taking part
- Infinity Medical ResearchNorth Dartmouth, United StatesNo longer taking part
- Great Plains HealthNorth Platte, United StatesNo longer taking part
- Nuvance HealthNorwalk, United StatesNo longer taking part
- Henry Ford Health (Sleep Research Department)Novi, United StatesNo longer taking part
- Renstar Medical ResearchOcala, United StatesNo longer taking part
- UPMC Comprehensive Lung Center - Sleep MedicinePittsburgh, United StatesNo longer taking part
- Empire Clinical ResearchPomona, United StatesNo longer taking part
- Northwest Research CenterPortland, United StatesNo longer taking part
- Meridian Clinical ResearchRaleigh, United StatesNo longer taking part
- Centricity Research Rincon PulmonologyRincon, United StatesNo longer taking part
- Velocity Clinical ResearchRockville, United StatesNo longer taking part
- Central Texas Neurology Consultants, PARound Rock, United StatesNo longer taking part
- Sleep Therapy Research CenterSan Antonio, United StatesNo longer taking part
- Pacific Research NetworkSan Diego, United StatesNo longer taking part
- SDS Clinical Trials, Inc.Santa Ana, United StatesNo longer taking part
- Baystate Medical Center (BMC) - Baystate Sleep MedicineSpringfield, United StatesNo longer taking part
- Clayton Sleep InstituteSt Louis, United StatesNo longer taking part
- Clinical Neurophysiology ServicesSterling Heights, United StatesNo longer taking part
- Medster ResearchValdosta, United StatesNo longer taking part
- Sleep Disorders Centers of the Mid-AtlanticVienna, United StatesNo longer taking part
- Palm Beach Research ClinEdge-PPDSWest Palm Beach, United StatesNo longer taking part
- Clinical Site Partners, LLC dba Flourish ResearchWinter Park, United StatesNo longer taking part
Trial details
- Who runs it
- Apnimed
- Trial code
- NCT05811247
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: ≥18 years of age at the time of informed consent; PSG criteria: AHI of >5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15; PROMIS-Fatigue: raw score ≥17; PAP intolerance or current PAP refusal; BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive.
Exclusion: Narcolepsy, restless leg syndrome, REM sleep behavior disorder; 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; Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy; Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed; Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.