Back to resultsCrossover Trial of AD109 in Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AD109
Atomoxetine
R-oxybutynin
Placebo
Digit System Substitution Test
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 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
- Preferred Research Partners, Inc.
- Empire Clinical Research
- Yale University
- Teradan Clinical Trials
- Clinical Trials of Florida
- The Neurological Center of North Georgia
- CTI Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
AD109
Atomoxetine
R-oxybutynin
Placebo
Arm Description
Oral capsule administered before sleep
Oral capsule administered before sleep
Oral capsule administered before sleep
Oral capsule administered before sleep
Outcomes
Primary Outcome Measures
Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]
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/hour]. Events with 4% or greater desaturations were included in the calculation of HB.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04580394
Brief Title
Crossover Trial of AD109 in Obstructive Sleep Apnea
Official Title
Phase 2 Randomized Double-Blind Placebo-Controlled 4-Period Single-Dose Crossover Factorial Study to Evaluate the Contribution of the Individual Drug Components to the Efficacy of AD109 in Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
May 28, 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, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual components or placebo in patients with obstructive sleep apnea.
Detailed Description
The study is designed to examine the efficacy and safety of AD109 to treat obstructive sleep apnea. The study is a four-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 4 treatments: AD109, atomoxetine, R-oxybutynin or placebo. Participants will return 2 weeks 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
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AD109
Arm Type
Experimental
Arm Description
Oral capsule administered before sleep
Arm Title
Atomoxetine
Arm Type
Active Comparator
Arm Description
Oral capsule administered before sleep
Arm Title
R-oxybutynin
Arm Type
Active Comparator
Arm Description
Oral capsule administered before sleep
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral capsule administered before sleep
Intervention Type
Drug
Intervention Name(s)
AD109
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)
R-oxybutynin
Intervention Description
Oral administration before bed
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration before bed
Intervention Type
Diagnostic Test
Intervention Name(s)
Digit System Substitution Test
Other Intervention Name(s)
DSST
Intervention Description
a neuropsychological test sensitive to brain damage, dementia, age and depression where numbers are assigned symbols. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.
Primary Outcome Measure Information:
Title
Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]
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/hour]. Events with 4% or greater desaturations were included in the calculation of HB.
Time Frame
1 night (treatment duration) (0-8 hours collected continuously)
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 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.
Facility Information:
Facility Name
Preferred Research Partners, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Empire Clinical Research
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Teradan Clinical Trials
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Clinical Trials of Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
The Neurological Center of North Georgia
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
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
Learn more about this trial
Crossover Trial of AD109 in Obstructive Sleep Apnea
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