Crossover Trial of AD109 in Obstructive Sleep Apnea

Phase 2

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: R-oxybutynin; Drug: Placebo; Drug: AD109; Drug: Atomoxetine; Diagnostic Test: Digit System Substitution Test

• Registration Number: NCT04580394
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-10-02
• Study First Posted: 2020-10-08
• Study Start: 2020-10-27
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Results First Submitted: 2022-11-16
• Status Verified: 2022-12
• Results First Submitted QC: 2023-01-12
• Last Update Submitted: 2023-01-12
• Results First Posted: 2023-01-31
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
R-oxybutynin	R-oxybutynin	Oral capsule administered before sleep
Atomoxetine	Digit System Substitution Test	Oral capsule administered before sleep
AD109	Digit System Substitution Test	Oral capsule administered before sleep
Placebo	Placebo	Oral capsule administered before sleep
Placebo	Digit System Substitution Test	Oral capsule administered before sleep
R-oxybutynin	Digit System Substitution Test	Oral capsule administered before sleep
AD109	AD109	Oral capsule administered before sleep
Atomoxetine	Atomoxetine	Oral capsule administered before sleep

Primary Outcome Measures

Name	Time	Method
Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]	1 night (treatment duration) (0-8 hours collected continuously)	Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Due to the known logarithmic distribution of HB, data are primarily expressed and analyzed as Log10HB 4%\[% min/hour\]. Events with 4% or greater desaturations were included in the calculation of HB.

Trial Locations

Locations (7)

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

Yale University; 🇺🇸 New Haven, Connecticut, United States

Teradan Clinical Trials; 🇺🇸 Brandon, Florida, United States

Clinical Trials of Florida; 🇺🇸 Miami, Florida, United States

Empire Clinical Research; 🇺🇸 Pomona, California, United States

The Neurological Center of North Georgia; 🇺🇸 Gainesville, Georgia, United States

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