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NCT04631107

AD109 Dose Finding in Mild to Moderate OSA

NCT ID: NCT04631107

Last Updated: 2022-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-22

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sequence ABC

AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B), then Placebo (C).

Group Type OTHER

AD109 dose1- A

Intervention Type DRUG

Oral administration at bedtime

AD109 dose2- B

Intervention Type DRUG

Oral administration at bedtime

Placebo- C

Intervention Type DRUG

Oral administration at bedtime

Sequence ACB

AD109 Dose 1- 75 mg (A), then Placebo (C) then AD109 Dose 2- 37.5 mg (B)

Group Type OTHER

AD109 dose1- A

Intervention Type DRUG

Oral administration at bedtime

AD109 dose2- B

Intervention Type DRUG

Oral administration at bedtime

Placebo- C

Intervention Type DRUG

Oral administration at bedtime

Sequence BAC

AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A), then Placebo (C)

Group Type OTHER

AD109 dose1- A

Intervention Type DRUG

Oral administration at bedtime

AD109 dose2- B

Intervention Type DRUG

Oral administration at bedtime

Placebo- C

Intervention Type DRUG

Oral administration at bedtime

Sequence BCA

AD109 Dose 2- 37.5 mg (B), then Placebo (C), then AD109 Dose 1- 75 mg (A)

Group Type OTHER

AD109 dose1- A

Intervention Type DRUG

Oral administration at bedtime

AD109 dose2- B

Intervention Type DRUG

Oral administration at bedtime

Placebo- C

Intervention Type DRUG

Oral administration at bedtime

Sequence CAB

Placebo (C), then AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B)

Group Type OTHER

AD109 dose1- A

Intervention Type DRUG

Oral administration at bedtime

AD109 dose2- B

Intervention Type DRUG

Oral administration at bedtime

Placebo- C

Intervention Type DRUG

Oral administration at bedtime

Sequence CBA

Placebo (C), then AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A)

Group Type OTHER

AD109 dose1- A

Intervention Type DRUG

Oral administration at bedtime

AD109 dose2- B

Intervention Type DRUG

Oral administration at bedtime

Placebo- C

Intervention Type DRUG

Oral administration at bedtime

Interventions

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AD109 dose1- A

Oral administration at bedtime

Intervention Type DRUG

AD109 dose2- B

Oral administration at bedtime

Intervention Type DRUG

Placebo- C

Oral administration at bedtime

Intervention Type DRUG

Other Intervention Names

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AD109 75 AD109 37.5

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Apnimed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ron Farkas, MD

Role: STUDY_DIRECTOR

Apnimed

Locations

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Pacific Research Network

San Diego, California, United States

Site Status

NeuroTrial Research

Atlanta, Georgia, United States

Site Status

Brian Abaluck, LLC

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT

PMID: 35975547 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

Document Type: Statistical Analysis Plan

Other Identifiers

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APC-004

Identifier Type: -

Identifier Source: org_study_id