Crossover Trial of AD036 in Obstructive Sleep Apnea

Apnimed

Status and phase: Completed; Phase 2

Conditions: Obstructive Sleep Apnea

Treatments: Drug: Atomoxetine; Drug: AD036; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04445688

APN-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 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 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

---

62 participants in 3 patient groups, including a placebo group

AD036

Experimental group

Description:

AD036 oral capsule administered before sleep

Treatment:

Drug: AD036

Atomoxetine

Active Comparator group

Description:

Atomoxetine oral capsule administered before sleep

Treatment:

Drug: Atomoxetine

Placebo

Placebo Comparator group

Description:

Placebo oral capsule administered before sleep

Treatment:

Drug: Placebo