Crossover Trial of AD036 in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Phase 2, Randomized, 3-Period, Placebo-Controlled Crossover Study to Evaluate the Efficacy and Safety in Obstructive Sleep Apnea of AD036 Versus Placebo or Atomoxetine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445688
• Other study ID #: APN-006
• Status: Completed
• Phase: Phase 2
• Start date: July 15, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: September 2023
• Source: Apnimed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• AD036
Oral administration before bed
• Atomoxetine
Oral administration before bed
• Placebo
Oral administration before bed

Locations

Country	Name	City	State
United States	Sleep Medicine & Research Center, St. Luke's Hospital	Chesterfield	Missouri
United States	The Center for Sleep and Wake Disorders	Chevy Chase	Maryland
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Preferred Research Partners, Inc.	Little Rock	Arkansas
United States	SDS Clinical Trials, Inc.	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
Apnimed

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schweitzer PK, Maynard JP, Wylie PE, Emsellem HA, Sands SA. Efficacy of atomoxetine plus oxybutynin in the treatment of obstructive sleep apnea with moderate pharyngeal collapsibility. Sleep Breath. 2023 May;27(2):495-503. doi: 10.1007/s11325-022-02634-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-Hypopnea Index	Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo	1 day
Secondary	Hypoxic Burden	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	1 day
Secondary	ODI	Oxygen Desaturation Index, measured by pulse-oximetry, AD036 vs. placebo	1 day