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AD109 Dose Finding in Mild to Moderate OSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04631107
Recruitment Status : Completed
First Posted : November 17, 2020
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
Apnimed

Brief Summary:
This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: AD109 dose1 Drug: AD109 dose2 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 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 3-Period Single-Dose Crossover Study to Evaluate the Safety and Efficacy of Two Doses of AD-109 in Mild to Moderate Obstructive Sleep Apnea
Actual Study Start Date : December 22, 2020
Actual Primary Completion Date : May 31, 2021
Actual Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: AD109 dose1 Drug: AD109 dose1
Oral administration at bedtime

Experimental: AD109 dose2 Drug: AD109 dose2
Oral administration at bedtime

Placebo Comparator: Placebo Drug: Placebo
Oral administration at bedtime




Primary Outcome Measures :
  1. Change in Hypoxic Burden (HB) [ Time Frame: 1 night (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 [ Time Frame: 1 night (8 hours) ]
    AD109 dose1 and AD109 dose2 vs placebo



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:

  • AHI between 5 and 20 events/h
  • PGI-S equal to or higher than 1, or one or more of the following symptoms:

    • Snoring or nightime gasping/choking
    • Daytime sleepiness, fatigue or decreased concentration
    • Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning headache
    • Irritability, decreased mood or libido

Exclusion Criteria:

  • History of narcolepsy.
  • 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).
  • CPAP should not be used for at least 2 weeks prior to the study
  • 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): NCT04631107


Locations
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United States, California
Pacific Research Network
San Diego, California, United States, 92103
United States, Georgia
NeuroTrial Research
Atlanta, Georgia, United States, 30328
United States, Pennsylvania
Brian Abaluck, LLC
Philadelphia, Pennsylvania, United States, 19063
Sponsors and Collaborators
Apnimed
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Responsible Party: Apnimed
ClinicalTrials.gov Identifier: NCT04631107    
Other Study ID Numbers: APC-004
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: June 25, 2021
Last Verified: March 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