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Completed

NCT Number: NCT05071612

Parallel Arm Trial of AD109 and AD504 In Patients With OSA

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.

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Key information

Conditions

OSA - Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Santa Monica Clinical Trials, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AD109

Drug

Oral administration at bedtime

AD504

Drug

Oral administration at bedtime

Atomoxetine Hydrochloride

Drug

Oral administration at bedtime

Placebo

Drug

Oral administration at bedtime

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Apnimed

Industry

Registry information

Official study 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

Acronym: MARIPOSA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2021
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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