Back to resultsCrossover Trial of AD182 and AD504 in Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AD182
AD504
Placebo
Polysomnography
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
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.
Sites / Locations
- Intrepid research, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
AD182
AD504
Placebo
Arm Description
Oral capsule administered before bed
Oral capsule administered before bed
Oral capsule administered before bed
Outcomes
Primary Outcome Measures
Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)
Apnea-Hypopnea Index, AD182 and AD504 vs placebo
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04645524
Brief Title
Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
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
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AD182
Arm Type
Experimental
Arm Description
Oral capsule administered before bed
Arm Title
AD504
Arm Type
Experimental
Arm Description
Oral capsule administered before bed
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral capsule administered before bed
Intervention Type
Drug
Intervention Name(s)
AD182
Intervention Description
Oral capsule administered before bed
Intervention Type
Drug
Intervention Name(s)
AD504
Intervention Description
Oral capsule administered before bed
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral capsule administered before bed
Intervention Type
Diagnostic Test
Intervention Name(s)
Polysomnography
Intervention Description
for all arms
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)
Description
Apnea-Hypopnea Index, AD182 and AD504 vs placebo
Time Frame
1 night (treatment duration)
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Corser, MD
Organizational Affiliation
Intrepid Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intrepid research, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea
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