Crossover Trial of AD109 in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Phase 2 Randomized Double-Blind Placebo-Controlled 4-Period Single-Dose Crossover Factorial Study to Evaluate the Contribution of the Individual Drug Components to the Efficacy of AD109 in Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580394
• Other study ID #: APC-003
• Status: Completed
• Phase: Phase 2
• Start date: October 27, 2020
• Est. completion date: May 28, 2021

Study information

• Verified date: December 2022
• Source: Apnimed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• 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 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• AD109
Oral administration before bed
• Atomoxetine
Oral administration before bed
• R-oxybutynin
Oral administration before bed
• Placebo
Oral administration before bed

Diagnostic Test:
• Digit System Substitution Test
a neuropsychological test sensitive to brain damage, dementia, age and depression where numbers are assigned symbols. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.

Locations

Country	Name	City	State
United States	Teradan Clinical Trials	Brandon	Florida
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	The Neurological Center of North Georgia	Gainesville	Georgia
United States	Preferred Research Partners, Inc.	Little Rock	Arkansas
United States	Clinical Trials of Florida	Miami	Florida
United States	Yale University	New Haven	Connecticut
United States	Empire Clinical Research	Pomona	California

Sponsors (1)

Lead Sponsor	Collaborator
Apnimed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]	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.	1 night (treatment duration) (0-8 hours collected continuously)