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

Phase 3

Completed

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

• 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

Study Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Study First Posted: 2023-04-13
• Study Start: 2023-08-28
• Status Verified: 2025-05
• Primary Completion: 2025-05-07
• Study Completion: 2025-05-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

1. ≥18 years of age at the time of informed consent.
2. PSG criteria: AHI of >5; ≤ 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.

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

Trial Locations

Locations (63)

Sleep Disorders Center of Alabama; 🇺🇸 Birmingham, Alabama, United States

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

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