Parallel Arm Trial of AD109 and AD504 In Patients With OSA

OSA - Obstructive Sleep Apnea Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071612
• Other study ID #: MARIPOSA
• Status: Completed
• Phase: Phase 2
• Start date: November 29, 2021
• Est. completion date: August 3, 2022

Study information

• Verified date: December 2022
• Source: Apnimed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: August 3, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• OSA - Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	NeuroTrials Research, Inc.	Atlanta	Georgia
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Teradan Clinical Trials	Brandon	Florida
United States	St. Luke's Hospital Sleep Medicine	Chesterfield	Missouri
United States	The Center for Sleep & Wake Disorders	Chevy Chase	Maryland
United States	Chicago Research Center	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Intrepid Research	Cincinnati	Ohio
United States	Delta Waves	Colorado Springs	Colorado
United States	Bogan Sleep Consultants LLC	Columbia	South Carolina
United States	Henry Ford Hospital	Detroit	Michigan
United States	Sleep Disorders Centers of the Mid-Atlantic (SDCMA)	Glen Burnie	Maryland
United States	Velocity Clinical Research	Greenville	South Carolina
United States	Research Centers of America -- Hollywood	Hollywood	Florida
United States	Santa Monica Clinical Trials	Los Angeles	California
United States	Brian Abaluck, LLC	Malvern	Pennsylvania
United States	Clayton Sleep Institute	Maplewood	Missouri
United States	Sleep Medicine Specialists of South Florida	Miami	Florida
United States	Coastal Carolina Health Care, P.A.	New Bern	North Carolina
United States	Clinilabs	New York	New York
United States	Neurocare	Newton	Massachusetts
United States	Pacific Research Network	San Diego	California
United States	SDS Clinical Trials, Inc.	Santa Ana	California
United States	Sleep and Attention Disorders Institute	Sterling Heights	Michigan
United States	Minnesota Lung Center / Minnesota Sleep Institute	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Apnimed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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