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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05071612
Recruitment Status : Completed
First Posted : October 8, 2021
Last Update Posted : December 12, 2022
Sponsor:
Information provided by (Responsible Party):
Apnimed

Tracking Information
First Submitted Date  ICMJE September 27, 2021
First Posted Date  ICMJE October 8, 2021
Last Update Posted Date December 12, 2022
Actual Study Start Date  ICMJE November 29, 2021
Actual Primary Completion Date July 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Parallel Arm Trial of AD109 and AD504 In Patients With OSA
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE OSA - Obstructive Sleep Apnea
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2022)
294
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2021)
280
Actual Study Completion Date  ICMJE August 3, 2022
Actual Primary Completion Date July 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05071612
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Current Responsible Party Apnimed
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Apnimed
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Apnimed
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP