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Trial of AD036 in Obstructive Sleep Apnea

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: NCT03845023
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Apnimed

Brief Summary:
This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels of AD036 versus placebo in patients with obstructive sleep apnea.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: AD036 Dose 1 Drug: AD036 Dose 2 Drug: AD036 Dose 3 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Placebo-Controlled, Parallel Group Dose-Finding Study to Evaluate the Efficacy and Safety of Three Dose Levels of AD036 in Adults With Obstructive Sleep Apnea
Actual Study Start Date : March 7, 2019
Actual Primary Completion Date : October 23, 2019
Actual Study Completion Date : October 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo oral capsule administered before sleep

Active Comparator: Dose 1
AD036 Dose 1
Drug: AD036 Dose 1
AD036 Dose 1 oral capsule administered before sleep

Active Comparator: Dose 2
AD036 Dose 2
Drug: AD036 Dose 2
AD036 Dose 2 oral capsule administered before sleep

Active Comparator: Dose 3
AD036 Dose 3
Drug: AD036 Dose 3
AD036 Dose 3 oral capsule administered before sleep




Primary Outcome Measures :
  1. Apnea Hypopnea Index (AHI) [ Time Frame: 10 days ]
    Proportion of participants with ≥50% reduction in apnea hypopnea index (AHI)


Secondary Outcome Measures :
  1. Oxygen Desaturation Index [ Time Frame: 10 days ]
  2. Epworth Sleepiness Scale [ Time Frame: 10 days ]
    The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. In general ESS scores can be interpreted as follows:0-5 Lower Normal Daytime Sleepiness 6-10 Higher Normal Daytime Sleepiness 11-12 Mild Excessive Daytime Sleepiness 13-15 Moderate Excessive Daytime Sleepiness 16-24 Severe Excessive Daytime Sleepiness



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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Male participants between 25 to 65 years of age or female participants between 25 to 70 years of age.

Key Inclusion Criteria:

  • AHI ≥ 20 based on screening polysomnography
  • Epworth Sleepiness Scale (ESS) score ≥ 4 for participants not using CPAP
  • Previous surgical treatment for OSA is allowed if ≥ 1 year prior to enrollment

Key Exclusion Criteria:

  • 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.
  • Clinically significant neurological disorder, including epilepsy/convulsions.
  • Positive screen for drugs of abuse or substance use disorder as defined in DSM-V within 24 months prior to Screening Visit.
  • A significant illness or infection requiring medical treatment in the past 30 days.
  • Women who are pregnant or nursing.
  • 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.
  • History of using devices to affect participant sleeping position for the treatment of OSA, e.g. to discourage supine sleeping position, may enroll as long as the devices are not used during participation in the study.
  • Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, strong cytochrome P450 2D6 (CYP2D6) inhibitors, or monoamine oxidase inhibitors (MAOI) within 14 days of the start of treatment, or concomitant with treatment.
  • Use of another investigational agent within 90 days or 5 half-lives, whichever is longer, prior to dosing.
  • ESS total score > 18.
  • Central apnea index > 5/hour on baseline PSG.
  • Periodic limb movement arousal index >15/hour on baseline PSG.
  • Hepatic transaminases >3X the upper limit of normal (ULN), total bilirubin >2X ULN (unless confirmed Gilbert syndrome), serum creatinine >2X ULN.
  • <6 hours typical sleep duration.
  • Night- or shift-work sleep schedule.
  • Employment as a commercial driver or operator of heavy or hazardous equipment.

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): NCT03845023


Locations
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United States, Arizona
Pulmonary Associates
Glendale, Arizona, United States, 85306
United States, Arkansas
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States, 72211
United States, California
Stanford Sleep Medicine
Redwood City, California, United States, 94063
SDS Clinical Trials, Inc.
Santa Ana, California, United States, 92705
Santa Monica Clinical Trials
Santa Monica, California, United States, 90404
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Kentucky
Norton Clinical Research Group
Louisville, Kentucky, United States, 40218
United States, Maryland
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States, 20815
United States, Missouri
Sleep Medicine & Research Center, St. Luke's Hospital
Chesterfield, Missouri, United States, 63017
United States, New York
Clinilabs Drug Development Corporation
New York, New York, United States, 10019
United States, Ohio
CTI Clinical Research Center
Cincinnati, Ohio, United States, 45212
United States, Texas
Sleep Therapy & Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Apnimed
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Responsible Party: Apnimed
ClinicalTrials.gov Identifier: NCT03845023    
Other Study ID Numbers: APN-002
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases