Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)

Phase 3

Active, not recruiting

• Conditions: OSA
• Interventions: Drug: Placebo; Drug: AD109

• Registration Number: NCT05813275
• Lead Sponsor: Apnimed

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-14
• Study Start: 2023-09-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

1. ≥18 years of age at the time of informed consent.
2. PSG criteria: AHI of ≥10 and ≤45; ≤ 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.

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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:

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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 sever OSA	6 months	Proportion of participants with reduction in AHI (AHI, average number of events for every hour of sleep), measured by polysomnography

Trial Locations

Locations (73)

Alabama Neurology & Sleep Medicine; 🇺🇸 Tuscaloosa, Alabama, United States

Desert Clinical Research - CCT Research; 🇺🇸 Mesa, Arizona, United States

Foothills Research Center - CCT Research; 🇺🇸 Phoenix, Arizona, United States

Fiel Family Sports Medicine - PC CCT Research; 🇺🇸 Tempe, Arizona, United States

Noble Clinical Research; 🇺🇸 Tucson, Arizona, United States

Preferred Research Partners, Inc.; 🇺🇸 Little Rock, Arkansas, United States

Orange County Research Institute; 🇺🇸 Anaheim, California, United States

North County Neurology Associates; 🇺🇸 Carlsbad, California, United States

Core Healthcare Group; 🇺🇸 Cerritos, California, United States

Exalt Clinical Research; 🇺🇸 Chula Vista, California, United States

Catalina Research Institute; 🇺🇸 Montclair, California, United States

Probe Clinical Research Corporation; 🇺🇸 Riverside, California, 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

Providere' Research Incorporated; 🇺🇸 West Covina, California, United States

Meris Clinical Research; 🇺🇸 Brandon, Florida, United States

Nouvelle Clinical Research; 🇺🇸 Cutler Bay, Florida, United States

Accel Research Sites; 🇺🇸 DeLand, Florida, United States

Research Centers of America, LLC; 🇺🇸 Hollywood, Florida, United States

Canvas Clinical Research; 🇺🇸 Lake Worth, Florida, United States

Florida Lung and Sleep Associates; 🇺🇸 Lehigh Acres, Florida, United States

Advanced Medical Research Institute; 🇺🇸 Miami, Florida, United States

Clinical Site Partners; 🇺🇸 Miami, Florida, United States

Clinical Neuroscience Solutions, Inc - Orlando; 🇺🇸 Orlando, Florida, United States

JSV Clinical Research Study Inc; 🇺🇸 Tampa, Florida, United States

Florida Pediatric Research Institute; 🇺🇸 Winter Park, Florida, United States

Atlanta Center for Medical Research, LLC; 🇺🇸 Atlanta, Georgia, United States

NeuroTrials Research; 🇺🇸 Atlanta, Georgia, United States

Georgia Neurology and Sleep Medicine Assoc; 🇺🇸 Suwanee, Georgia, United States

Javarra Inc-Privia Medical Group; 🇺🇸 Thomasville, Georgia, United States

St. Lukes Clinic - Idaho Pulmonary Associates; 🇺🇸 Meridian, Idaho, United States

Chicago Research Center Inc; 🇺🇸 Chicago, Illinois, United States

OSF HealthCare Saint Francis Medical Center; 🇺🇸 Peoria, Illinois, United States

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Advanced ENT and Allergy; 🇺🇸 Louisville, Kentucky, United States

Centennial Medical Group; 🇺🇸 Elkridge, Maryland, United States

Infinity Medical Research; 🇺🇸 North Dartmouth, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Revive Research Institute; 🇺🇸 Lathrup Village, Michigan, United States

Las Vegas Clinical Trials; 🇺🇸 North Las Vegas, Nevada, United States

Neurology Specialists of Monmouth County; 🇺🇸 West Long Branch, New Jersey, United States

Javara Inc - Tryon Medical Partners PLCC; 🇺🇸 Charlotte, North Carolina, United States

Research Carolina Elite; 🇺🇸 Denver, North Carolina, United States

Peters Medical Research, LLC; 🇺🇸 High Point, North Carolina, United States

PMG Research of Wilmington; 🇺🇸 Wilmington, North Carolina, United States

Lillestol Research LLC; 🇺🇸 Fargo, North Dakota, United States

CTI Clinical Research Center; 🇺🇸 Cincinnati, Ohio, United States

Sleep Management Institute (Intrepid); 🇺🇸 Cincinnati, Ohio, United States

UC Health Sleep Medicine; 🇺🇸 Cincinnati, Ohio, United States

University Hospital of Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Abington Neurological Associate; 🇺🇸 Abington, Pennsylvania, United States

Respiratory Specialists; 🇺🇸 Wyomissing, Pennsylvania, United States

Tribe Clinical Research LL; 🇺🇸 Greenville, South Carolina, United States

OnSite Clinical Solutions LLC/Carolina Cardiology Associates P.A; 🇺🇸 Rock Hill, South Carolina, United States

Chattanooga Research & Medicine, PLLC; 🇺🇸 Chattanooga, Tennessee, United States

FutureSearch Trials of Neurology; 🇺🇸 Austin, Texas, United States

FutureSearch Trials of Dallas, LP; 🇺🇸 Dallas, Texas, United States

The Heights Hospital (HD Heights); 🇺🇸 Houston, Texas, United States

Weill Cornell Medical College; 🇺🇸 Houston, Texas, United States

Lone Star Lung and Sleep Clinic; 🇺🇸 Houston, Texas, United States

Huntsville Research Institute LLC; 🇺🇸 Huntsville, Texas, United States

Epic Medical Research; 🇺🇸 Red Oak, Texas, United States

Element Research Group; 🇺🇸 San Antonio, Texas, United States

South Ogden Family Medicine / CCT Research; 🇺🇸 South Ogden, Utah, United States

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

Toronto Sleep Institute; 🇨🇦 Toronto, Ontario, Canada

Sleep and Alertness Center; 🇨🇦 Toronto, Ontario, Canada

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada