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

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ClinicalTrials.gov Identifier: NCT05071612
Recruitment Status : Not yet recruiting
First Posted : October 8, 2021
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Apnimed

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.

Condition or disease Intervention/treatment Phase
OSA - Obstructive Sleep Apnea Drug: AD109 Drug: AD504 Drug: Atomoxetine Hydrochloride Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 15, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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

Placebo Comparator: Placebo 1 Drug: Placebo
Oral administration at bedtime

Placebo Comparator: Placebo 2 Drug: Placebo
Oral administration at bedtime




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05071612


Contacts
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Contact: Ron Farkas, MD 617-500-8880 info@apnimed.com
Contact: Luigi Taranto, MD

Sponsors and Collaborators
Apnimed
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Responsible Party: Apnimed
ClinicalTrials.gov Identifier: NCT05071612    
Other Study ID Numbers: MARIPOSA
First Posted: October 8, 2021    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs