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

Primary Purpose

OSA - Obstructive Sleep Apnea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AD109
AD504
Atomoxetine Hydrochloride
Placebo
Sponsored by
Apnimed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for OSA - Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Santa Monica Clinical Trials
  • Pacific Research Network
  • SDS Clinical Trials, Inc.
  • Delta Waves
  • Teradan Clinical Trials
  • Research Centers of America -- Hollywood
  • Sleep Medicine Specialists of South Florida
  • NeuroTrials Research, Inc.
  • Chicago Research Center
  • The Center for Sleep & Wake Disorders
  • Sleep Disorders Centers of the Mid-Atlantic (SDCMA)
  • Neurocare
  • Henry Ford Hospital
  • Sleep and Attention Disorders Institute
  • Minnesota Lung Center / Minnesota Sleep Institute
  • St. Luke's Hospital Sleep Medicine
  • Clayton Sleep Institute
  • Clinilabs
  • Coastal Carolina Health Care, P.A.
  • CTI Clinical Research Center
  • Intrepid Research
  • Brian Abaluck, LLC
  • Bogan Sleep Consultants LLC
  • Velocity Clinical Research
  • FutureSearch Trials of Neurology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

AD109 Dose 1

AD109 Dose 2

AD504 Dose 1

AD504 Dose 2

Atomoxetine 1

Atomoxetine 2

Placebo 1

Placebo 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in AHI, combined AD504 dose arms vs. combined placebo arms
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
Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography

Full Information

First Posted
September 27, 2021
Last Updated
December 5, 2022
Sponsor
Apnimed
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1. Study Identification

Unique Protocol Identification Number
NCT05071612
Brief Title
Parallel Arm Trial of AD109 and AD504 In Patients With OSA
Acronym
MARIPOSA
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
August 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apnimed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OSA - Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
294 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AD109 Dose 1
Arm Type
Experimental
Arm Title
AD109 Dose 2
Arm Type
Experimental
Arm Title
AD504 Dose 1
Arm Type
Experimental
Arm Title
AD504 Dose 2
Arm Type
Experimental
Arm Title
Atomoxetine 1
Arm Type
Active Comparator
Arm Title
Atomoxetine 2
Arm Type
Active Comparator
Arm Title
Placebo 1
Arm Type
Placebo Comparator
Arm Title
Placebo 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AD109
Intervention Description
Oral administration at bedtime
Intervention Type
Drug
Intervention Name(s)
AD504
Intervention Description
Oral administration at bedtime
Intervention Type
Drug
Intervention Name(s)
Atomoxetine Hydrochloride
Intervention Description
Oral administration at bedtime
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration at bedtime
Primary Outcome Measure Information:
Title
Change in AHI, combined AD109 dose arms vs. combined placebo arms
Description
Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Change in AHI, combined AD504 dose arms vs. combined placebo arms
Description
Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography
Time Frame
28 Days
Title
Change in AHI, combined atomoxetine dose arms vs. combined placebo arms
Description
Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography
Time Frame
28 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Santa Monica Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
SDS Clinical Trials, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Delta Waves
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Teradan Clinical Trials
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Research Centers of America -- Hollywood
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Sleep Medicine Specialists of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
NeuroTrials Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Chicago Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
The Center for Sleep & Wake Disorders
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Sleep Disorders Centers of the Mid-Atlantic (SDCMA)
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Neurocare
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Sleep and Attention Disorders Institute
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Facility Name
Minnesota Lung Center / Minnesota Sleep Institute
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
St. Luke's Hospital Sleep Medicine
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Clayton Sleep Institute
City
Maplewood
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States
Facility Name
Clinilabs
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Coastal Carolina Health Care, P.A.
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Intrepid Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Brian Abaluck, LLC
City
Malvern
State/Province
Pennsylvania
ZIP/Postal Code
19355
Country
United States
Facility Name
Bogan Sleep Consultants LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Velocity Clinical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Parallel Arm Trial of AD109 and AD504 In Patients With OSA

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