AD109 Dose Finding in Mild to Moderate OSA

Apnimed32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

AD109 dose1- ADRUG

Oral administration at bedtime

AD109 dose2- BDRUG

Oral administration at bedtime

Placebo- CDRUG

Oral administration at bedtime

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (3)

Pacific Research Network

San Diego, California, United States

NeuroTrial Research

Atlanta, Georgia, United States

Brian Abaluck, LLC

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 night (8 hours)

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.

Time frame: 1 night (8 hours)

Data from ClinicalTrials.gov

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