AD109 Dose Finding in Mild to Moderate OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

Phase 2 Randomized Double-Blind Placebo-Controlled 3-Period Single-Dose Crossover Study to Evaluate the Safety and Efficacy of Two Doses of AD-109 in Mild to Moderate Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04631107
• Other study ID #: APC-004
• Status: Completed
• Phase: Phase 2
• Start date: December 22, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: November 2022
• 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 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.

Description:

Participants underwent initial pre-screening to determine potential study eligibility. Participants selected for further screening had either a previous history of OSA of a severity consistent with enrollment criteria or were at high risk (e.g. as assessed by STOP-Bang Questionnaire score). Only participants who met all non polysomnography (PSG) enrollment criteria at Visit 1 were eligible for a screening PSG.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• AHI between 5 and 20 events/h

• PGI-S equal to or higher than 1, or one or more of the following symptoms:

• Snoring or nightime gasping/choking

• Daytime sleepiness, fatigue or decreased concentration

• Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning headache

• Irritability, decreased mood or libido

Exclusion Criteria:

• History of narcolepsy.

• Clinically significant craniofacial malformation.

• Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).

• CPAP should not be used for at least 2 weeks prior to the study

• 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

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

Intervention

Drug:
• AD109 dose1- A
Oral administration at bedtime
• AD109 dose2- B
Oral administration at bedtime
• Placebo- C
Oral administration at bedtime

Locations

Country	Name	City	State
United States	NeuroTrial Research	Atlanta	Georgia
United States	Brian Abaluck, LLC	Philadelphia	Pennsylvania
United States	Pacific Research Network	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Apnimed

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rosenberg R, Abaluck B, Thein S. Combination of atomoxetine with the novel antimuscarinic aroxybutynin improves mild to moderate OSA. J Clin Sleep Med. 2022 Dec 1;18(12):2837-2844. doi: 10.5664/jcsm.10250. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h]	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/h]. Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.	1 night (8 hours)
Primary	Change in Hypoxic Burden (HB) Raw Values - HB[(%*Min)/h]	Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas.; Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.	1 night (8 hours)