Trial of AD036 in Obstructive Sleep Apnea



Status:Recruiting
Conditions:Insomnia Sleep Studies, Pulmonary, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:25 - 65
Updated:3/15/2019
Start Date:March 7, 2019
End Date:December 30, 2019
Contact:Ron Farkas, MD
Email:info@apnimed.com
Phone:617-394-8172

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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

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.


Key Inclusion Criteria:

- AHI ≥ 20 based on screening polysomnography

- Epworth Sleepiness Scale (ESS) score ≥ 8 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.
We found this trial at
10
sites
Louisville, Kentucky 40218
Principal Investigator: David Winslow, MD
Phone: 502-479-1217
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Chesterfield, Missouri 63017
Principal Investigator: Paula K Schweitzer, PhD
Phone: 314-205-6011
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Chesterfield, MO
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Chevy Chase, Maryland 20815
Principal Investigator: Helene Emsellem, MD
Phone: 301-654-5665
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Chevy Chase, MD
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Cincinnati, Ohio 45227
Principal Investigator: James P Maynard, MD
Phone: 513-721-3868
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Cincinnati, OH
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Glendale, Arizona 85306
Principal Investigator: Mark Gotfried, MD
Phone: 602-515-0230
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Glendale, AZ
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Little Rock, Arkansas 72211
Principal Investigator: Paul E Wylie, MD
Phone: 501-553-9987
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Little Rock, AR
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New York, New York 07724
Principal Investigator: Mardik Donikyan, DO
Phone: 212-994-4563
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New York, NY
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San Antonio, Texas 78229
Principal Investigator: James Andry, MD
Phone: 210-614-6000
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San Antonio, TX
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Santa Ana, California 92705
Principal Investigator: Andrew O Schreiber, MD
Phone: 714-834-1565
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Santa Ana, CA
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Santa Monica, California 90404
Principal Investigator: Daniel Norman, MD
Phone: 310-586-0843
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Santa Monica, CA
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