OSA - Obstructive Sleep ApneaPhase 2MARIPOSANCT05071612
Parallel Arm Trial of AD109 and AD504 In Patients With OSA
A Phase 2 study testing AD109, AD504 and Atomoxetine Hydrochloride in people with OSA - Obstructive Sleep Apnea, run by Apnimed at 25 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- OSA - Obstructive Sleep Apnea
- What is being tested?
- AD109, AD504 and Atomoxetine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 25 sitesUnited States
- Study dates
- 29 Nov 2021to 3 Aug 2022
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
NeuroTrials Research, Inc.
Atlanta, Georgia, 30328
FutureSearch Trials of Neurology
Austin, Texas, 78731
Teradan Clinical Trials
Brandon, Florida, 33511
St. Luke's Hospital Sleep Medicine
Chesterfield, Missouri, 63017
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815
Chicago Research Center
Chicago, Illinois, 60634
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Intrepid Research
Cincinnati, Ohio, 45245
Delta Waves
Colorado Springs, Colorado, 80918
Bogan Sleep Consultants LLC
Columbia, South Carolina, 29201
Henry Ford Hospital
Detroit, Michigan, 48377
Sleep Disorders Centers of the Mid-Atlantic (SDCMA)
Glen Burnie, Maryland, 21061
Velocity Clinical Research
Greenville, South Carolina, 29615
Research Centers of America -- Hollywood
Hollywood, Florida, 33024
Santa Monica Clinical Trials
Los Angeles, California, 90025
Brian Abaluck, LLC
Malvern, Pennsylvania, 19355
Clayton Sleep Institute
Maplewood, Missouri, 63143
Sleep Medicine Specialists of South Florida
Miami, Florida, 33176
Coastal Carolina Health Care, P.A.
New Bern, North Carolina, 28562
Clinilabs
New York, New York, 10016
Neurocare
Newton, Massachusetts, 02459
Pacific Research Network
San Diego, California, 92103
SDS Clinical Trials, Inc.
Santa Ana, California, 92705
Sleep and Attention Disorders Institute
Sterling Heights, Michigan, 48314
Minnesota Lung Center / Minnesota Sleep Institute
Woodbury, Minnesota, 55125
About this study
Official title: 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
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.
- Conditions
- OSA - Obstructive Sleep Apnea
- Being tested
- AD109, AD504, Atomoxetine Hydrochloride, Placebo
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD109Drug
Oral administration at bedtime
AD504Drug
Oral administration at bedtime
Atomoxetine HydrochlorideDrug
Oral administration at bedtime
PlaceboDrug
Oral administration at bedtime
| Study group | Role | What they receive |
|---|---|---|
| AD109 75/5mg | Experimental | Atomoxetine 75 mg/Aroxybutynin 5 mg tablet Receives: Drug: AD109 |
| AD109 75/2.5mg | Experimental | Atomoxetine 75 mg/Aroxybutynin 2.5 mg tablet Receives: Drug: AD109 |
| AD504 75/100mg | Experimental | Atomoxetine 75 mg tablet/Trazodone 100 mg capsule Receives: Drug: AD504 |
| AD504 75/50mg | Experimental | Atomoxetine 75 mg tablet/Trazodone 50 mg capsule Receives: Drug: AD504 |
| Atomoxetine 75mg | Active comparator | Atomoxetine 75 mg tablet Receives: Drug: Atomoxetine Hydrochloride |
| Atomoxetine 75mg plus placebo | Active comparator | Atomoxetine 75 mg tablet/placebo capsule Receives: Drug: Atomoxetine Hydrochloride |
| Placebo tablet | Placebo comparator | Not described Receives: Drug: Placebo |
| Placebo tablet plus placebo capsule | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start29 Nov 2021
- Primary completion20 Jul 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OSA - Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apnimed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071612
- Sponsor's protocol ID
- MARIPOSA
- Acronym
- MARIPOSA
- Status last verified
- Aug 2026
- First submitted
- 27 Sep 2021
- Last updated
- 12 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 37812772