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

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.

Study Overview

• Status: Completed
• Conditions: OSA - Obstructive Sleep Apnea
• Intervention / Treatment: Drug: AD109; Drug: AD504; Drug: Atomoxetine Hydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90025
      • Santa Monica Clinical Trials
    • San Diego, California, United States, 92103
      • Pacific Research Network
    • Santa Ana, California, United States, 92705
      • SDS Clinical Trials, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Delta Waves
  • Florida
    • Brandon, Florida, United States, 33511
      • Teradan Clinical Trials
    • Hollywood, Florida, United States, 33024
      • Research Centers of America -- Hollywood
    • Miami, Florida, United States, 33176
      • Sleep Medicine Specialists of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • NeuroTrials Research, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60634
      • Chicago Research Center
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • The Center for Sleep & Wake Disorders
    • Glen Burnie, Maryland, United States, 21061
      • Sleep Disorders Centers of the Mid-Atlantic (SDCMA)
  • Massachusetts
    • Newton, Massachusetts, United States, 02459
      • NeuroCare
  • Michigan
    • Detroit, Michigan, United States, 48377
      • Henry Ford Hospital
    • Sterling Heights, Michigan, United States, 48314
      • Sleep and Attention Disorders Institute
  • Minnesota
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Lung Center / Minnesota Sleep Institute
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • St. Luke's Hospital Sleep Medicine
    • Maplewood, Missouri, United States, 63143
      • Clayton Sleep Institute
  • New York
    • New York, New York, United States, 10016
      • Clinilabs
  • North Carolina
    • New Bern, North Carolina, United States, 28562
      • Coastal Carolina Health Care, P.A.
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45245
      • Intrepid Research
  • Pennsylvania
    • Malvern, Pennsylvania, United States, 19355
      • Brian Abaluck, LLC
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants LLC
    • Greenville, South Carolina, United States, 29615
      • Velocity Clinical Research
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo 1	Drug: Placebo; Oral administration at bedtime
Placebo Comparator: Placebo 2	Drug: Placebo; Oral administration at bedtime
Experimental: AD109 Dose 1	Drug: AD109; Oral administration at bedtime
Experimental: AD109 Dose 2	Drug: AD109; Oral administration at bedtime
Experimental: AD504 Dose 1	Drug: AD504; Oral administration at bedtime
Experimental: AD504 Dose 2	Drug: AD504; Oral administration at bedtime
Active Comparator: Atomoxetine 1	Drug: Atomoxetine Hydrochloride; Oral administration at bedtime
Active Comparator: Atomoxetine 2	Drug: Atomoxetine Hydrochloride; Oral administration at bedtime

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 Days
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	28 Days

Collaborators and Investigators

• Sponsor: Apnimed

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): August 3, 2022

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Atomoxetine Hydrochloride
• Other Study ID Numbers: MARIPOSA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No