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

February 7, 2024 updated by: Apnimed

Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (LunAIRo Study)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

640

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Recruiting
        • Sleep Disorders Center of Alabama
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Chandler Clinical Trials
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Preferred Research Partners, Inc.
    • California
      • Anaheim, California, United States, 92801
        • Recruiting
        • Orange County Research Institute
      • Huntington Beach, California, United States, 92647
        • Active, not recruiting
        • Marvel Clinical Research, LLC
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • CenExel CNS
      • Los Angeles, California, United States, 90025
        • Recruiting
        • Santa Monica Clinical Trials
      • Pomona, California, United States, 91767
        • Recruiting
        • Empire Clinical Research
      • San Diego, California, United States, 92103
        • Recruiting
        • Pacific Research Network
      • Santa Ana, California, United States, 92705
        • Recruiting
        • SDS Clinical Trials Inc.
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Recruiting
        • Alpine Clinical Research Center
      • Denver, Colorado, United States, 80209
        • Recruiting
        • Mountain View Clinical Research, Inc.
    • Connecticut
      • Norwalk, Connecticut, United States, 06850
        • Recruiting
        • Nuvance Health
    • Florida
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Teradan Clinical trials LLC
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • St. Francis Medical Institute
      • Cutler Bay, Florida, United States, 33189
        • Recruiting
        • Nouvelle Clinical Research
      • Daytona Beach, Florida, United States, 32117
        • Recruiting
        • Arrow Clinical Trials
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Cenexel Research Centers of America - Hollywood
      • Miami, Florida, United States, 33155
        • Recruiting
        • Ivetmar Medical Group LLC
      • Miami, Florida, United States, 33176
        • Recruiting
        • PharmaDev Clinical Research Institute, LLC
      • Ocala, Florida, United States, 34470
        • Recruiting
        • Renstar Medical Research
      • West Palm Beach, Florida, United States, 33409
        • Recruiting
        • Palm Beach Research ClinEdge-PPDS
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Clinical Site Partners, LLC dba Flourish Research
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • Neurotrials Research
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExel iResearch
      • Macon, Georgia, United States, 31210
        • Recruiting
        • Sleep Practitioners, LLC
      • Rincon, Georgia, United States, 31326
        • Recruiting
        • Centricity Research Rincon Pulmonology
      • Valdosta, Georgia, United States, 31605
        • Recruiting
        • Medster Research
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Recruiting
        • Chicago Research Center Inc
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • Sleep Disorders Centers of the Mid-Atlantic
      • Rockville, Maryland, United States, 20854
        • Recruiting
        • Velocity Clinical Research
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • Recruiting
        • Neurocare, Inc
      • North Dartmouth, Massachusetts, United States, 02747
        • Recruiting
        • Infinity Medical Research
      • Springfield, Massachusetts, United States, 01199
        • Recruiting
        • Baystate Medical Center (BMC) - Baystate Sleep Medicine
    • Michigan
      • Kalamazoo, Michigan, United States, 49008
        • Recruiting
        • Western Michigan University Homer Stryker M.D. School of Medicine
      • Novi, Michigan, United States, 48377
        • Recruiting
        • Henry Ford Health (Sleep Research Department)
      • Sterling Heights, Michigan, United States, 48314
        • Recruiting
        • Clinical Neurophysiology Services
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Recruiting
        • St Lukes Hospital
      • Hazelwood, Missouri, United States, 63042
        • Recruiting
        • Healthcare Research Network
      • Saint Louis, Missouri, United States, 63123
        • Recruiting
        • Clayton Sleep Institute
    • Nebraska
      • North Platte, Nebraska, United States, 69101
        • Recruiting
        • Great Plains Health
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Henderson Clinical Trials
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Recruiting
        • Clinilabs, Inc
    • New Mexico
      • Albuquerque, New Mexico, United States, 87107
        • Recruiting
        • Maimonides Sleep Arts and Sciences
    • New York
      • New Hyde Park, New York, United States, 11042
        • Recruiting
        • Northwell Health Physician Partners
    • North Carolina
      • Denver, North Carolina, United States, 28037
        • Recruiting
        • Research Carolina Elite
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Clinical Research of Gastonia
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Advanced Respiratory and Sleep Medicine, LLC
      • New Bern, North Carolina, United States, 28562
        • Recruiting
        • Coastal Carolina Health Care
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Meridian Clinical Research
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • NeuroScience Research Center, LLC
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • CTI Clinical Research Center
      • Cincinnati, Ohio, United States, 45245
        • Recruiting
        • Sleep Management Institute
      • Dublin, Ohio, United States, 43017
        • Recruiting
        • Ohio Sleep Medicine Institute
    • Oregon
      • Portland, Oregon, United States, 97202
        • Recruiting
        • Northwest Research Center
    • Pennsylvania
      • Malvern, Pennsylvania, United States, 19355
        • Active, not recruiting
        • Brian Abaluck, LLC
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Comprehensive Lung Center - Sleep Medicine
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Recruiting
        • Lowcountry Lung and Critical Care
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Velocity Clinical Research - Greenville
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Clinical Neuroscience Solutions - Memphis
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • FutureSearch Trials of Neurology
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Central Texas Neurology Consultants, PA
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Sleep Therapy Research Center
    • Virginia
      • Vienna, Virginia, United States, 22182
        • Recruiting
        • Sleep Disorders Centers of the Mid-Atlantic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral administration at bedtime.
Experimental: AD109
Drug: AD109
Oral administration at bedtime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of AD109 on airway obstruction in mild to severe OSA
Time Frame: 6 months
Proportion of participants with reduction in AHI (AHI, average number of events for every hour of sleep), measured by polysomnography
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apnimed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APC-APN-304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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