Parallel Arm Trial of AD109 and AD504 In Patients With OSA
MARIPOSA
Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of AD109 and AD504 to Atomoxetine or Placebo in Obstructive Sleep Apnea
1 other identifier
interventional
294
1 country
25
Brief Summary
This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2021
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
October 8, 2021
CompletedStudy Start
First participant enrolled
November 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2022
CompletedResults Posted
Study results publicly available
August 12, 2026
CompletedAugust 12, 2026
August 1, 2026
8 months
September 27, 2021
June 4, 2026
August 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD109 Arms vs. Placebo
Change in AHI4 (apnea-hypopnea index, 4% oxygen desaturation criterion; average respiratory events per hour of sleep) measured by in-lab polysomnography. Baseline was the mean of two pre-treatment PSG nights (Visits 2 and 3). Change from baseline was assessed at treatment PSG nights at approximately Day 21 (Visit 5) and Day 28 (Visit 6), modeled as repeated measures, with the reported value representing the model-based LS mean using equal (0.5/0.5) weighting between the Day 21 and Day 28 visits.
Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)
Secondary Outcomes (2)
Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD504 Arms vs. Placebo
Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)
Change in Apnea-Hypopnea Index (AHI4) From Baseline: Atomoxetine vs. Placebo
Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)
Study Arms (8)
AD109 75/5mg
EXPERIMENTALAtomoxetine 75 mg/Aroxybutynin 5 mg tablet
AD109 75/2.5mg
EXPERIMENTALAtomoxetine 75 mg/Aroxybutynin 2.5 mg tablet
AD504 75/100mg
EXPERIMENTALAtomoxetine 75 mg tablet/Trazodone 100 mg capsule
AD504 75/50mg
EXPERIMENTALAtomoxetine 75 mg tablet/Trazodone 50 mg capsule
Atomoxetine 75mg
ACTIVE COMPARATORAtomoxetine 75 mg tablet
Atomoxetine 75mg plus placebo
ACTIVE COMPARATORAtomoxetine 75 mg tablet/placebo capsule
Placebo tablet
PLACEBO COMPARATORPlacebo tablet plus placebo capsule
PLACEBO COMPARATORInterventions
Oral administration at bedtime
Eligibility Criteria
You may qualify if:
- Between 18 to 65 years of age for men and 18-75 for women, inclusive, at the Screening Visit.
- Mean AHI 10 to 45 events/h, inclusive
- PGI-S: \>1
- BMI between 18.5 and 38 kg/m2 for men and 40 kg/m2 for women, inclusive.
You may not qualify if:
- Current clinically significant sleep disorder other than OSA
- Clinically significant craniofacial malformation.
- Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
- Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first PSG and are not used during participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Apnimedlead
Study Sites (25)
Santa Monica Clinical Trials
Los Angeles, California, 90025, United States
Pacific Research Network
San Diego, California, 92103, United States
SDS Clinical Trials, Inc.
Santa Ana, California, 92705, United States
Delta Waves
Colorado Springs, Colorado, 80918, United States
Teradan Clinical Trials
Brandon, Florida, 33511, United States
Research Centers of America -- Hollywood
Hollywood, Florida, 33024, United States
Sleep Medicine Specialists of South Florida
Miami, Florida, 33176, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, 30328, United States
Chicago Research Center
Chicago, Illinois, 60634, United States
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815, United States
Sleep Disorders Centers of the Mid-Atlantic (SDCMA)
Glen Burnie, Maryland, 21061, United States
Neurocare
Newton, Massachusetts, 02459, United States
Henry Ford Hospital
Detroit, Michigan, 48377, United States
Sleep and Attention Disorders Institute
Sterling Heights, Michigan, 48314, United States
Minnesota Lung Center / Minnesota Sleep Institute
Woodbury, Minnesota, 55125, United States
St. Luke's Hospital Sleep Medicine
Chesterfield, Missouri, 63017, United States
Clayton Sleep Institute
Maplewood, Missouri, 63143, United States
Clinilabs
New York, New York, 10016, United States
Coastal Carolina Health Care, P.A.
New Bern, North Carolina, 28562, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Intrepid Research
Cincinnati, Ohio, 45245, United States
Brian Abaluck, LLC
Malvern, Pennsylvania, 19355, United States
Bogan Sleep Consultants LLC
Columbia, South Carolina, 29201, United States
Velocity Clinical Research
Greenville, South Carolina, 29615, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Related Publications (1)
Schweitzer PK, Taranto-Montemurro L, Ojile JM, Thein SG, Drake CL, Rosenberg R, Corser B, Abaluck B, Sangal RB, Maynard J. The Combination of Aroxybutynin and Atomoxetine in the Treatment of Obstructive Sleep Apnea (MARIPOSA): A Randomized Controlled Trial. Am J Respir Crit Care Med. 2023 Dec 15;208(12):1316-1327. doi: 10.1164/rccm.202306-1036OC.
PMID: 37812772DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This Phase 2 study was not powered to compare individual dose groups. Primary efficacy analyses evaluated prespecified pooled treatment groups, and results for individual dose arms should be interpreted descriptively.
Results Point of Contact
- Title
- Luigi Taranto Montemurro
- Organization
- Apnimed
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2021
First Posted
October 8, 2021
Study Start
November 29, 2021
Primary Completion
July 20, 2022
Study Completion
August 3, 2022
Last Updated
August 12, 2026
Results First Posted
August 12, 2026
Record last verified: 2026-08