Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)
- Registration Number
- NCT05811247
- Lead Sponsor
- Apnimed
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 660
- ≥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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo AD109 AD109 AD109
- Primary Outcome Measures
Name Time Method Efficacy of AD109 on airway obstruction in mild to severe OSA 6 months Proportion of participants with reduction in AHI (AHI, average number of events for every hour of sleep), measured by polysomnography
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (63)
Santa Monica Clinical Trials
🇺🇸Los Angeles, California, United States
Coastal Carolina Health Care
🇺🇸New Bern, North Carolina, United States
NeuroTrials Research
🇺🇸Atlanta, Georgia, United States
CenExel iResearch
🇺🇸Decatur, Georgia, United States
Henry Ford Health (Sleep Research Department)
🇺🇸Novi, Michigan, United States
Healthcare Research Network
🇺🇸Hazelwood, Missouri, United States
Ivetmar Medical Group LLC
🇺🇸Miami, Florida, United States
PharmaDev Clinical Research Institute, LLC
🇺🇸Miami, Florida, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Ohio Sleep Medicine Institute
🇺🇸Dublin, Ohio, United States
Brian Abaluck, LLC
🇺🇸Malvern, Pennsylvania, United States
Velocity Clinical Research - Greenville
🇺🇸Greenville, South Carolina, United States
Preferred Research Partners, Inc.
🇺🇸Little Rock, Arkansas, United States
Chandler Clinical Trials
🇺🇸Chandler, Arizona, United States
Clinilabs, Inc
🇺🇸Eatontown, New Jersey, United States
Nuvance Health
🇺🇸Norwalk, Connecticut, United States
Clinical Neuroscience Solutions - Memphis
🇺🇸Memphis, Tennessee, United States
Henderson Clinical Trials
🇺🇸Henderson, Nevada, United States
Great Plains Health
🇺🇸North Platte, Nebraska, United States
UPMC Comprehensive Lung Center - Sleep Medicine
🇺🇸Pittsburgh, Pennsylvania, United States
Central Texas Neurology Consultants, PA
🇺🇸Round Rock, Texas, United States
Orange County Research Institute
🇺🇸Anaheim, California, United States
Marvel Clinical Research, LLC
🇺🇸Huntington Beach, California, United States
CenExel CNS
🇺🇸Los Alamitos, California, United States
Empire Clinical Research
🇺🇸Pomona, California, United States
SDS Clinical Trials Inc.
🇺🇸Santa Ana, California, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Mountain View Clinical Research, Inc.
🇺🇸Denver, Colorado, United States
Teradan Clinical trials LLC
🇺🇸Brandon, Florida, United States
Nouvelle Clinical Research
🇺🇸Cutler Bay, Florida, United States
St. Francis Medical Institute
🇺🇸Clearwater, Florida, United States
Arrow Clinical Trials
🇺🇸Daytona Beach, Florida, United States
Cenexel Research Centers of America - Hollywood
🇺🇸Hollywood, Florida, United States
Palm Beach Research ClinEdge-PPDS
🇺🇸West Palm Beach, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
🇺🇸Winter Park, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Sleep Practitioners, LLC
🇺🇸Macon, Georgia, United States
Centricity Research Rincon Pulmonology
🇺🇸Rincon, Georgia, United States
Chicago Research Center Inc
🇺🇸Chicago, Illinois, United States
Medster Research
🇺🇸Valdosta, Georgia, United States
Velocity Clinical Research
🇺🇸Rockville, Maryland, United States
Sleep Disorders Centers of the Mid-Atlantic
🇺🇸Vienna, Virginia, United States
Infinity Medical Research
🇺🇸North Dartmouth, Massachusetts, United States
Baystate Medical Center (BMC) - Baystate Sleep Medicine
🇺🇸Springfield, Massachusetts, United States
Neurocare, Inc
🇺🇸Newton, Massachusetts, United States
Western Michigan University Homer Stryker M.D. School of Medicine
🇺🇸Kalamazoo, Michigan, United States
St Lukes Hospital
🇺🇸Chesterfield, Missouri, United States
Clinical Neurophysiology Services
🇺🇸Sterling Heights, Michigan, United States
Clayton Sleep Institute
🇺🇸Saint Louis, Missouri, United States
Maimonides Sleep Arts and Sciences
🇺🇸Albuquerque, New Mexico, United States
Northwell Health Physician Partners
🇺🇸New Hyde Park, New York, United States
Research Carolina Elite
🇺🇸Denver, North Carolina, United States
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
Advanced Respiratory and Sleep Medicine, LLC
🇺🇸Huntersville, North Carolina, United States
Meridian Clinical Research
🇺🇸Raleigh, North Carolina, United States
NeuroScience Research Center, LLC
🇺🇸Canton, Ohio, United States
Sleep Disorders Center of Alabama
🇺🇸Birmingham, Alabama, United States
Pacific Research Network
🇺🇸San Diego, California, United States
Northwest Research Center
🇺🇸Portland, Oregon, United States
Sleep Therapy Research Center
🇺🇸San Antonio, Texas, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Sleep Management Institute
🇺🇸Cincinnati, Ohio, United States
Lowcountry Lung and Critical Care
🇺🇸Charleston, South Carolina, United States