Back to resultsCrossover Trial of AD036 in Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AD036
Atomoxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
- AHI 10 to <20, or AHI ≥20 if meets 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
- Preferred Research Partners, Inc.
- SDS Clinical Trials, Inc.
- The Center for Sleep and Wake Disorders
- Sleep Medicine & Research Center, St. Luke's Hospital
- CTI Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
AD036
Atomoxetine
Placebo
Arm Description
AD036 oral capsule administered before sleep
Atomoxetine oral capsule administered before sleep
Placebo oral capsule administered before sleep
Outcomes
Primary Outcome Measures
Apnea-Hypopnea Index
Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo
Secondary Outcome Measures
Hypoxic Burden
Hypoxic burden (a way to measure oxygen desaturation) determined by measuring the respiratory event-associated area under the desaturation curve from pre-event baseline, AD036 vs. placebo. Hypoxic Burden was measured during polysomnography (type of sleep study), while the patient was asleep
ODI
Oxygen Desaturation Index, measured by pulse-oximetry, AD036 vs. placebo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04445688
Brief Title
Crossover Trial of AD036 in Obstructive Sleep Apnea
Official Title
Phase 2, Randomized, 3-Period, Placebo-Controlled Crossover Study to Evaluate the Efficacy and Safety in Obstructive Sleep Apnea of AD036 Versus Placebo or Atomoxetine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (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 AD036 versus placebo or atomoxetine in patients with obstructive sleep apnea.
Detailed Description
The study is designed to examine the efficacy and safety of AD036 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight Home Sleep Apnea Testing (HSAT) with dosing of one of the following 3 treatments: AD036, Atomoxetine, or Placebo. Participants will return 1 week after their final crossover HSAT 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
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AD036
Arm Type
Experimental
Arm Description
AD036 oral capsule administered before sleep
Arm Title
Atomoxetine
Arm Type
Active Comparator
Arm Description
Atomoxetine oral capsule administered before sleep
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral capsule administered before sleep
Intervention Type
Drug
Intervention Name(s)
AD036
Intervention Description
Oral administration before bed
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Intervention Description
Oral administration before bed
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration before bed
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index
Description
Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Hypoxic Burden
Description
Hypoxic burden (a way to measure oxygen desaturation) determined by measuring the respiratory event-associated area under the desaturation curve from pre-event baseline, AD036 vs. placebo. Hypoxic Burden was measured during polysomnography (type of sleep study), while the patient was asleep
Time Frame
1 day
Title
ODI
Description
Oxygen Desaturation Index, measured by pulse-oximetry, AD036 vs. placebo
Time Frame
1 day
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 to 65 years of age, inclusive, at the Screening Visit.
AHI 10 to <20, or AHI ≥20 if meets 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.
Facility Information:
Facility Name
Preferred Research Partners, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
SDS Clinical Trials, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
The Center for Sleep and Wake Disorders
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Sleep Medicine & Research Center, St. Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35551600
Citation
Schweitzer PK, Maynard JP, Wylie PE, Emsellem HA, Sands SA. Efficacy of atomoxetine plus oxybutynin in the treatment of obstructive sleep apnea with moderate pharyngeal collapsibility. Sleep Breath. 2023 May;27(2):495-503. doi: 10.1007/s11325-022-02634-x. Epub 2022 May 13.
Results Reference
result
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Crossover Trial of AD036 in Obstructive Sleep Apnea
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