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Crossover Trial of AD109 in Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT04580394
Recruitment Status : Completed
First Posted : October 8, 2020
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
Apnimed

Brief Summary:
This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual components or placebo in patients with obstructive sleep apnea.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: AD109 Drug: Atomoxetine Drug: R-oxybutynin Drug: Placebo Phase 2

Detailed Description:
The study is designed to examine the efficacy and safety of AD109 to treat obstructive sleep apnea. The study is a four-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 4 treatments: AD109, atomoxetine, R-oxybutynin or placebo. Participants will return 2 weeks after their final crossover PSG for an end of study (EOS) visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Randomized Double-Blind Placebo-Controlled 4-Period Single-Dose Crossover Factorial Study to Evaluate the Contribution of the Individual Drug Components to the Efficacy of AD109 in Obstructive Sleep Apnea
Actual Study Start Date : October 27, 2020
Actual Primary Completion Date : May 28, 2021
Actual Study Completion Date : May 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: AD109
Oral capsule administered before sleep
Drug: AD109
Oral administration before bed

Active Comparator: Atomoxetine
Oral capsule administered before sleep
Drug: Atomoxetine
Oral administration before bed

Active Comparator: R-oxybutynin
Oral capsule administered before sleep
Drug: R-oxybutynin
Oral administration before bed

Placebo Comparator: Placebo
Oral capsule administered before sleep
Drug: Placebo
Oral administration before bed




Primary Outcome Measures :
  1. Change in Hypoxic Burden (HB) [ Time Frame: 1 night (treatment duration) (8 hours) ]
    Change in Hypoxic Burden (HB is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas)


Secondary Outcome Measures :
  1. Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep) [ Time Frame: 1 night (treatment duration) (8 hours) ]
    Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
  • AHI 10 to <20, or AHI ≥20 if meets other PSG criteria

Exclusion Criteria:

  • History of narcolepsy.
  • Clinically significant craniofacial malformation.
  • Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
  • CPAP should not be used for at least 2 weeks prior to first study PSG
  • History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices 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): NCT04580394


Locations
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United States, Arkansas
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States, 72211
United States, California
Empire Clinical Research
Pomona, California, United States, 91767
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Florida
Teradan Clinical Trials
Brandon, Florida, United States, 33511
Clinical Trials of Florida
Miami, Florida, United States, 33186
United States, Georgia
The Neurological Center of North Georgia
Gainesville, Georgia, United States, 30501
United States, Ohio
CTI Clinical Research Center
Cincinnati, Ohio, United States, 45212
Sponsors and Collaborators
Apnimed
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Responsible Party: Apnimed
ClinicalTrials.gov Identifier: NCT04580394    
Other Study ID Numbers: APC-003
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: June 25, 2021
Last Verified: June 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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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Oxybutynin
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Urological Agents