Clinical trial NCT05811247: Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: OSA
Keywords: Obstructive Sleep Apnea
Lead sponsor: Apnimed
Sponsor class: INDUSTRY
First posted: 2023-04-13
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of AD109 on airway obstruction in mild to severe OSA
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Chandler
country: United States
facility: Chandler Clinical Trials
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc.
state: Arkansas
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research, LLC
state: California
city: Los Alamitos
country: United States
facility: CenExel CNS
state: California
city: Los Angeles
country: United States
facility: Santa Monica Clinical Trials
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: Santa Ana
country: United States
facility: SDS Clinical Trials Inc.
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Denver
country: United States
facility: Mountain View Clinical Research, Inc.
state: Colorado
city: Norwalk
country: United States
facility: Nuvance Health
state: Connecticut
city: Brandon
country: United States
facility: Teradan Clinical trials LLC
state: Florida
city: Clearwater
country: United States
facility: St. Francis Medical Institute
state: Florida
city: Cutler Bay
country: United States
facility: Nouvelle Clinical Research
state: Florida
city: Daytona Beach
country: United States
facility: Arrow Clinical Trials
state: Florida
city: Hollywood
country: United States
facility: Cenexel Research Centers of America - Hollywood
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group LLC
state: Florida
city: Miami
country: United States
facility: PharmaDev Clinical Research Institute, LLC
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research ClinEdge-PPDS
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC dba Flourish Research
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research
state: Georgia
city: Decatur
country: United States
facility: CenExel iResearch
state: Georgia
city: Macon
country: United States
facility: Sleep Practitioners, LLC
state: Georgia
city: Rincon
country: United States
facility: Centricity Research Rincon Pulmonology
state: Georgia
city: Valdosta
country: United States
facility: Medster Research
state: Georgia
city: Chicago
country: United States
facility: Chicago Research Center Inc
state: Illinois
city: Glen Burnie
country: United States
facility: Sleep Disorders Centers of the Mid-Atlantic
state: Maryland
city: Rockville
country: United States
facility: Velocity Clinical Research
state: Maryland
city: Newton
country: United States
facility: Neurocare, Inc
state: Massachusetts
city: North Dartmouth
country: United States
facility: Infinity Medical Research
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center (BMC) - Baystate Sleep Medicine
state: Massachusetts
city: Kalamazoo
country: United States
facility: Western Michigan University Homer Stryker M.D. School of Medicine
state: Michigan
city: Novi
country: United States
facility: Henry Ford Health (Sleep Research Department)
state: Michigan
city: Sterling Heights
country: United States
facility: Clinical Neurophysiology Services
state: Michigan
city: Chesterfield
country: United States
facility: St Lukes Hospital
state: Missouri
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: North Platte
country: United States
facility: Great Plains Health
state: Nebraska
city: Henderson
country: United States
facility: Henderson Clinical Trials
state: Nevada
city: Eatontown
country: United States
facility: Clinilabs, Inc
state: New Jersey
city: Albuquerque
country: United States
facility: Maimonides Sleep Arts and Sciences
state: New Mexico
city: New Hyde Park
country: United States
facility: Northwell Health Physician Partners
state: New York
city: Denver
country: United States
facility: Research Carolina Elite
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: Huntersville
country: United States
facility: Advanced Respiratory and Sleep Medicine, LLC
state: North Carolina
city: New Bern
country: United States
facility: Coastal Carolina Health Care
state: North Carolina
city: Raleigh
country: United States
facility: Meridian Clinical Research
state: North Carolina
city: Canton
country: United States
facility: NeuroScience Research Center, LLC
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Sleep Management Institute
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Portland
country: United States
facility: Northwest Research Center
state: Oregon
city: Malvern
country: United States
facility: Brian Abaluck, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Comprehensive Lung Center - Sleep Medicine
state: Pennsylvania
city: Charleston
country: United States
facility: Lowcountry Lung and Critical Care
state: South Carolina
city: Greenville
country: United States
facility: Velocity Clinical Research - Greenville
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions - Memphis
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology Consultants, PA
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy Research Center
state: Texas
city: Vienna
country: United States
facility: Sleep Disorders Centers of the Mid-Atlantic
state: Virginia
Study officials:
References: