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AD109 Dose Finding in Mild to Moderate OSA

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AD109 dose1- A
AD109 dose2- B
Placebo- C
Sponsored by
Apnimed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pacific Research Network
  • NeuroTrial Research
  • Brian Abaluck, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Other

Other

Other

Other

Other

Arm Label

Sequence ABC

Sequence ACB

Sequence BAC

Sequence BCA

Sequence CAB

Sequence CBA

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2020
Last Updated
November 30, 2022
Sponsor
Apnimed
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1. Study Identification

Unique Protocol Identification Number
NCT04631107
Brief Title
AD109 Dose Finding in Mild to Moderate OSA
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apnimed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence ABC
Arm Type
Other
Arm Description
AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B), then Placebo (C).
Arm Title
Sequence ACB
Arm Type
Other
Arm Description
AD109 Dose 1- 75 mg (A), then Placebo (C) then AD109 Dose 2- 37.5 mg (B)
Arm Title
Sequence BAC
Arm Type
Other
Arm Description
AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A), then Placebo (C)
Arm Title
Sequence BCA
Arm Type
Other
Arm Description
AD109 Dose 2- 37.5 mg (B), then Placebo (C), then AD109 Dose 1- 75 mg (A)
Arm Title
Sequence CAB
Arm Type
Other
Arm Description
Placebo (C), then AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B)
Arm Title
Sequence CBA
Arm Type
Other
Arm Description
Placebo (C), then AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A)
Intervention Type
Drug
Intervention Name(s)
AD109 dose1- A
Other Intervention Name(s)
AD109 75
Intervention Description
Oral administration at bedtime
Intervention Type
Drug
Intervention Name(s)
AD109 dose2- B
Other Intervention Name(s)
AD109 37.5
Intervention Description
Oral administration at bedtime
Intervention Type
Drug
Intervention Name(s)
Placebo- C
Intervention Description
Oral administration at bedtime
Primary Outcome Measure Information:
Title
Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h]
Description
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)
Title
Change in Hypoxic Burden (HB) Raw Values - HB[(%*Min)/h]
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Farkas, MD
Organizational Affiliation
Apnimed
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
NeuroTrial Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Brian Abaluck, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35975547
Citation
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.
Results Reference
result

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AD109 Dose Finding in Mild to Moderate OSA

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