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

Phase 3

Completed

• 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
• Primary Completion: 2025-03-10
• Study Completion: 2025-03-14
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 646

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.

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:

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

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