Loading clinical trials...

COMPLETEDPHASE3

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

Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (SynAIRgy Study)

NCT05813275•Apnimed

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•\-

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

Key Dates

Start Date

September 16, 2023

Primary Completion Date

March 10, 2025

Completion Date

March 14, 2025

Last Updated

November 21, 2025

Enrollment

646

ACTUAL participants

Conditions

OSA

Interventions

AD109

DRUG

Placebo

DRUG

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

View study

RECRUITINGPHASE1

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma

Cognitive Evaluation of Patients With Eating Disorders

Feasibility and Acceptability of Metacognitive Training for Eating Disorders in Adolescents With Anorexia Nervosa

Digital-supported Orofacial Myofunctional Therapy in OSA