Parallel Arm Trial of AD109 and AD504 In Patients With OSA (MARIPOSA)

• ClinicalTrials.gov Identifier: NCT05071612
• Recruitment Status: Completed
• First Posted: October 8, 2021
• Last Update Posted: December 12, 2022
• Sponsor: Apnimed
• Information provided by (Responsible Party): Apnimed

Tracking Information

• First Submitted Date: September 27, 2021
• First Posted Date: October 8, 2021
• Last Update Posted Date: December 12, 2022
• Actual Study Start Date: November 29, 2021
• Actual Primary Completion Date: July 20, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 28, 2021)

Change in AHI, combined AD109 dose arms vs. combined placebo arms [ Time Frame: 28 Days ]

Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 28, 2021)

• Change in AHI, combined AD504 dose arms vs. combined placebo arms [ Time Frame: 28 Days ]
  Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography
• Change in AHI, combined atomoxetine dose arms vs. combined placebo arms [ Time Frame: 28 Days ]
  Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: OSA - Obstructive Sleep Apnea

Intervention

• Drug: AD109
  Oral administration at bedtime
• Drug: AD504
  Oral administration at bedtime
• Drug: Atomoxetine Hydrochloride
  Oral administration at bedtime
• Drug: Placebo
  Oral administration at bedtime

Study Arms

• Experimental: AD109 Dose 1
  Intervention: Drug: AD109
• Experimental: AD109 Dose 2
  Intervention: Drug: AD109
• Experimental: AD504 Dose 1
  Intervention: Drug: AD504
• Experimental: AD504 Dose 2
  Intervention: Drug: AD504
• Active Comparator: Atomoxetine 1
  Intervention: Drug: Atomoxetine Hydrochloride
• Active Comparator: Atomoxetine 2
  Intervention: Drug: Atomoxetine Hydrochloride
• Placebo Comparator: Placebo 1
  Intervention: Drug: Placebo
• Placebo Comparator: Placebo 2
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 10, 2022): 294
• Original Estimated Enrollment (submitted: September 28, 2021): 280
• Actual Study Completion Date: August 3, 2022
• Actual Primary Completion Date: July 20, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05071612
• Other Study ID Numbers: MARIPOSA
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Apnimed
• Original Responsible Party: Same as current
• Current Study Sponsor: Apnimed
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Apnimed
• Verification Date: December 2022