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
CompletedDecember 12, 2022
December 1, 2022
8 months
September 27, 2021
December 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in AHI, combined AD109 dose arms vs. combined placebo arms
Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography
28 Days
Secondary Outcomes (2)
Change in AHI, combined AD504 dose arms vs. combined placebo arms
28 Days
Change in AHI, combined atomoxetine dose arms vs. combined placebo arms
28 Days
Study Arms (8)
AD109 Dose 1
EXPERIMENTALAD109 Dose 2
EXPERIMENTALAD504 Dose 1
EXPERIMENTALAD504 Dose 2
EXPERIMENTALAtomoxetine 1
ACTIVE COMPARATORAtomoxetine 2
ACTIVE COMPARATORPlacebo 1
PLACEBO COMPARATORPlacebo 2
PLACEBO COMPARATORInterventions
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
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)
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
December 12, 2022
Record last verified: 2022-12