AD109 Dose Finding in Mild to Moderate OSA

November 30, 2022 updated by: Apnimed

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • Pacific Research Network
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • NeuroTrial Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19063
        • Brian Abaluck, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sequence ABC
AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B), then Placebo (C).
Drug: AD109 dose1- A
Oral administration at bedtime
Other Names:
  • AD109 75
Drug: AD109 dose2- B
Oral administration at bedtime
Other Names:
  • AD109 37.5
Drug: Placebo- C
Oral administration at bedtime
Other: Sequence ACB
AD109 Dose 1- 75 mg (A), then Placebo (C) then AD109 Dose 2- 37.5 mg (B)
Drug: AD109 dose1- A
Oral administration at bedtime
Other Names:
  • AD109 75
Drug: AD109 dose2- B
Oral administration at bedtime
Other Names:
  • AD109 37.5
Drug: Placebo- C
Oral administration at bedtime
Other: Sequence BAC
AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A), then Placebo (C)
Drug: AD109 dose1- A
Oral administration at bedtime
Other Names:
  • AD109 75
Drug: AD109 dose2- B
Oral administration at bedtime
Other Names:
  • AD109 37.5
Drug: Placebo- C
Oral administration at bedtime
Other: Sequence BCA
AD109 Dose 2- 37.5 mg (B), then Placebo (C), then AD109 Dose 1- 75 mg (A)
Drug: AD109 dose1- A
Oral administration at bedtime
Other Names:
  • AD109 75
Drug: AD109 dose2- B
Oral administration at bedtime
Other Names:
  • AD109 37.5
Drug: Placebo- C
Oral administration at bedtime
Other: Sequence CAB
Placebo (C), then AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B)
Drug: AD109 dose1- A
Oral administration at bedtime
Other Names:
  • AD109 75
Drug: AD109 dose2- B
Oral administration at bedtime
Other Names:
  • AD109 37.5
Drug: Placebo- C
Oral administration at bedtime
Other: Sequence CBA
Placebo (C), then AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A)
Drug: AD109 dose1- A
Oral administration at bedtime
Other Names:
  • AD109 75
Drug: AD109 dose2- B
Oral administration at bedtime
Other Names:
  • AD109 37.5
Drug: Placebo- C
Oral administration at bedtime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h]
Time Frame: 1 night (8 hours)
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)
Change in Hypoxic Burden (HB) Raw Values - HB[(%*Min)/h]
Time Frame: 1 night (8 hours)

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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea Index
Time Frame: 1 night (8 hours)
AD109 dose1 and AD109 dose2 vs placebo
1 night (8 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apnimed

Investigators

  • Study Director: Ron Farkas, MD, Apnimed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2020

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 22, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APC-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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