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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05071612
Other study ID # MARIPOSA
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04076332 - How "Shared Decision Making Decision-aid" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan N/A