Crossover Trial of AD109 in Obstructive Sleep Apnea

Apnimed

Status and phase: Completed; Phase 2

Conditions: Obstructive Sleep Apnea

Treatments: Drug: Atomoxetine; Drug: R-oxybutynin; Drug: AD109; Drug: Placebo; Diagnostic Test: Digit System Substitution Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT04580394

APC-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

AD109

Experimental group

Description:

Oral capsule administered before sleep

Treatment:

Diagnostic Test: Digit System Substitution Test

Drug: AD109

Atomoxetine

Active Comparator group

Description:

Oral capsule administered before sleep

Treatment:

Diagnostic Test: Digit System Substitution Test

Drug: Atomoxetine

R-oxybutynin

Active Comparator group

Description:

Oral capsule administered before sleep

Treatment:

Diagnostic Test: Digit System Substitution Test

Drug: R-oxybutynin

Placebo

Placebo Comparator group

Description:

Oral capsule administered before sleep

Treatment:

Diagnostic Test: Digit System Substitution Test

Drug: Placebo