Crossover Trial of AD036 in Obstructive Sleep Apnea

Phase 2

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: Placebo; Drug: Atomoxetine; Drug: AD036

• Registration Number: NCT04445688
• Lead Sponsor: Apnimed

Brief Summary

This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with obstructive sleep apnea.

Detailed Description

The study is designed to examine the efficacy and safety of AD036 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight Home Sleep Apnea Testing (HSAT) with dosing of one of the following 3 treatments: AD036, Atomoxetine, or Placebo. Participants will return 1 week after their final crossover HSAT for an end of study (EOS) Visit.

Study Timeline

• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Study Start: 2020-07-15
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Disposition First Submitted: 2021-05-26
• Results First Submitted: 2023-07-19
• Results First Submitted QC: 2023-08-15
• Results First Posted: 2023-08-21
• Disposition First Posted: 2023-08-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo oral capsule administered before sleep
Atomoxetine	Atomoxetine	Atomoxetine oral capsule administered before sleep
AD036	AD036	AD036 oral capsule administered before sleep

Primary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index	1 day	Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo

Secondary Outcome Measures

Name	Time	Method
Hypoxic Burden	1 day	Hypoxic burden (a way to measure oxygen desaturation) determined by measuring the respiratory event-associated area under the desaturation curve from pre-event baseline, AD036 vs. placebo. Hypoxic Burden was measured during polysomnography (type of sleep study), while the patient was asleep
ODI	1 day	Oxygen Desaturation Index, measured by pulse-oximetry, AD036 vs. placebo

Trial Locations

Locations (5)

CTI Clinical Research Center; 🇺🇸 Cincinnati, Ohio, United States

Preferred Research Partners, Inc.; 🇺🇸 Little Rock, Arkansas, United States

Sleep Medicine & Research Center, St. Luke's Hospital; 🇺🇸 Chesterfield, Missouri, United States

SDS Clinical Trials, Inc.; 🇺🇸 Santa Ana, California, United States

The Center for Sleep and Wake Disorders; 🇺🇸 Chevy Chase, Maryland, United States