Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea

August 31, 2022 updated by: Apnimed

Phase 2 Randomized, Double Blind, Placebo-Controlled, Single-Dose, 3-Period Crossover Study to Evaluate the Efficacy of AD182, and AD504 in Obstructive Sleep Apnea

This is a randomized, 3-period, placebo-controlled, crossover study to examine the efficacy and safety of AD182 and AD504 versus placebo in patients with obstructive sleep apnea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is designed to examine the efficacy and safety of AD182 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 3 treatments: AD182, AD504, or Placebo. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.

Study Type

Interventional

Enrollment (Actual)

15

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
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Intrepid Research, 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

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female between 25 and 65 years of age, inclusive, at the time of the screening visit
  • AHI 10 to 55 events/h if meets other PSG criteria

Exclusion Criteria:

  • History of narcolepsy.
  • Clinically significant craniofacial malformation.
  • Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
  • CPAP should not be used for at least 2 weeks prior to first study PSG
  • 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
Experimental: AD182
Oral capsule administered before bed
Drug: AD182
Oral capsule administered before bed
Diagnostic test: Polysomnography
for all arms
Experimental: AD504
Oral capsule administered before bed
Diagnostic test: Polysomnography
for all arms
Drug: AD504
Oral capsule administered before bed
Placebo Comparator: Placebo
Oral capsule administered before bed
Diagnostic test: Polysomnography
for all arms
Drug: Placebo
Oral capsule administered before bed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)
Time Frame: 1 night (treatment duration)
Apnea-Hypopnea Index, AD182 and AD504 vs placebo
1 night (treatment duration)

Collaborators and Investigators

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

Sponsor

Apnimed

Investigators

  • Principal Investigator: Bruce Corser, MD, Intrepid Research

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 1, 2020

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

November 21, 2020

First Submitted That Met QC Criteria

November 21, 2020

First Posted (Actual)

November 27, 2020

Study Record Updates

Last Update Posted (Actual)

September 2, 2022

Last Update Submitted That Met QC Criteria

August 31, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APX-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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