Parallel Arm Trial of AD109 and AD504 In Patients With OSA
- 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.
- Acronym
- MARIPOSA
- Short title
- Parallel Arm Trial of AD109 and AD504 In Patients With OSA
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2022-08-03
- First posted
- 2021-10-08
- Registry last updated
- 2026-08-12
- Primary completion date
- 2022-07-20
- Start date
- 2021-11-29
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Apnimed
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05071612
- ClinicalTrials.gov ID
- NCT05071612
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD109 Arms vs. Placebo
Timeframe: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)
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.
Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD504 Arms vs. Placebo
Timeframe: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)
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.
Change in Apnea-Hypopnea Index (AHI4) From Baseline: Atomoxetine vs. Placebo
Timeframe: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)
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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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
- Santa Monica Clinical TrialsLos Angeles, United States
- Pacific Research NetworkSan Diego, United States
- SDS Clinical Trials, Inc.Santa Ana, United States
- Delta WavesColorado Springs, United States
- Teradan Clinical TrialsBrandon, United States
- Research Centers of America -- HollywoodHollywood, United States
- Sleep Medicine Specialists of South FloridaMiami, United States
- NeuroTrials Research, Inc.Atlanta, United States
- Chicago Research CenterChicago, United States
- The Center for Sleep & Wake DisordersChevy Chase, United States
- Sleep Disorders Centers of the Mid-Atlantic (SDCMA)Glen Burnie, United States
- NeurocareNewton, United States
- Henry Ford HospitalDetroit, United States
- Sleep and Attention Disorders InstituteSterling Heights, United States
- Minnesota Lung Center / Minnesota Sleep InstituteWoodbury, United States
- St. Luke's Hospital Sleep MedicineChesterfield, United States
- Clayton Sleep InstituteMaplewood, United States
- ClinilabsNew York, United States
- Coastal Carolina Health Care, P.A.New Bern, United States
- CTI Clinical Research CenterCincinnati, United States
- Intrepid ResearchCincinnati, United States
- Brian Abaluck, LLCMalvern, United States
- Bogan Sleep Consultants LLCColumbia, United States
- Velocity Clinical ResearchGreenville, United States
- FutureSearch Trials of NeurologyAustin, United States
- PubMed 37812772Related publication