Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)

Completed · Phase 3 · Has a placebo group

Conditions studied: OSA

In brief

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.

Key facts

Study ID

NCT05811247

Run by

Apnimed

People needed

660

Starts

2023-08-28

Expected to finish

2025-05-07

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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.

You may not qualify if…

• 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.

Where it is running

• Chandler Clinical Trials — Chandler, Arizona, United States
• Preferred Research Partners, Inc. — Little Rock, Arkansas, 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
• Santa Monica Clinical Trials — Los Angeles, California, United States
• Empire Clinical Research — Pomona, California, United States
• Pacific Research Network — San Diego, 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
• Nuvance Health — Norwalk, Connecticut, United States
• Teradan Clinical trials LLC — Brandon, Florida, 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 Research Centers of America - Hollywood — Hollywood, Florida, United States
• Ivetmar Medical Group LLC — Miami, Florida, United States
• PharmaDev Clinical Research Institute, LLC — Miami, Florida, United States
• Renstar Medical Research — Ocala, 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
• NeuroTrials Research — Atlanta, Georgia, United States
• CenExel iResearch — Decatur, Georgia, United States
• Sleep Disorders Center of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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