Obstructive Sleep ApneaPhase 2NCT04580394

Crossover Trial of AD109 in Obstructive Sleep Apnea

A Phase 2 study testing AD109, Atomoxetine and R-oxybutynin in people with Obstructive Sleep Apnea, run by Apnimed at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 25 to 65 years
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: AD109, Atomoxetine and R-oxybutynin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 7 sitesUnited States
Study dates: 27 Oct 2020to 28 May 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Teradan Clinical Trials
Brandon, Florida, 33511
CTI Clinical Research Center
Cincinnati, Ohio, 45212
The Neurological Center of North Georgia
Gainesville, Georgia, 30501
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
Clinical Trials of Florida
Miami, Florida, 33186
Yale University
New Haven, Connecticut, 06511
Empire Clinical Research
Pomona, California, 91767

Other trials in United States

About this study

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

Read the 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.

Conditions: Obstructive Sleep Apnea
Being tested: AD109, Atomoxetine, R-oxybutynin, Placebo, Digit System Substitution Test
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AD109Drug
Oral administration before bed
AtomoxetineDrug
Oral administration before bed
R-oxybutyninDrug
Oral administration before bed
PlaceboDrug
Oral administration before bed
Digit System Substitution TestDiagnostic test
Also called DSST
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.

Study groups in NCT04580394
Study group	Role	What they receive
AD109	Experimental	Oral capsule administered before sleep Receives: Drug: AD109; Diagnostic Test: Digit System Substitution Test
Atomoxetine	Active comparator	Oral capsule administered before sleep Receives: Drug: Atomoxetine; Diagnostic Test: Digit System Substitution Test
R-oxybutynin	Active comparator	Oral capsule administered before sleep Receives: Drug: R-oxybutynin; Diagnostic Test: Digit System Substitution Test
Placebo	Placebo comparator	Oral capsule administered before sleep Receives: Drug: Placebo; Diagnostic Test: Digit System Substitution Test

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 night (treatment duration) (0-8 hours collected continuously)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 202028 May 2021

First posted8 Oct 2020
Study start27 Oct 2020
Primary completion28 May 2021
Study completion28 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04580394
Sponsor's protocol ID: APC-003
Status last verified: Dec 2022
First submitted: 2 Oct 2020
Last updated: 31 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04580394
Acronym / sponsor ID: APC-003
Conditions: Obstructive Sleep Apnea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: ApnimedIndustry (pharma, biotech, devices)
Study start: 27 Oct 2020 (actual)
Primary completion: 28 May 2021 (actual)
Study completion: 28 May 2021 (actual)
First posted: 8 Oct 2020 (actual)
Results: Posted 31 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
AD109	Experimental	Drug: AD109, Diagnostic Test: Digit System Substitution TestOral capsule administered before sleep
Atomoxetine	Active comparator	Drug: Atomoxetine, Diagnostic Test: Digit System Substitution TestOral capsule administered before sleep
R-oxybutynin	Active comparator	Drug: R-oxybutynin, Diagnostic Test: Digit System Substitution TestOral capsule administered before sleep
Placebo	Placebo comparator	Drug: Placebo, Diagnostic Test: Digit System Substitution TestOral capsule administered before sleep

Who may qualify

Ages: 25 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AD109Oral administration before bed	Drug	AD109
AtomoxetineOral administration before bed	Drug	Atomoxetine
R-oxybutyninOral administration before bed	Drug	R-oxybutynin
PlaceboOral administration before bed	Drug	Placebo
Digit System Substitution TestAlso: DSSTa 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.	Diagnostic test	AD109, Atomoxetine, Placebo, R-oxybutynin

Primary outcome

Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]
Time frame: 1 night (treatment duration) (0-8 hours collected continuously)
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.

Results and safety

Results posted to the registry on 31 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	60	57

Primary outcome: Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]

Time frame: 1 night (treatment duration) (0-8 hours collected continuously). Least squares mean (95% Confidence Interval). Unit: Log10HB4%[%min/hour]

Measure	AD109 n = 59	Atomoxetine n = 59	R-oxybutynin n = 59	Placebo n = 59
Value	-0.41 (-0.54 to -0.28)	-0.36 (-0.49 to -0.23)	-0.04 (-0.17 to 0.09)	-0.06 (-0.18 to 0.07)

Population analysed: The efficacy was analyzed using the mITT Set comprised of all participants who took at least 1 dose of any of the study treatments and had at least 1 measurement for the primary endpoint. Fifty-nine (98.3%) participants were included in the mITT Population

Adverse events

Time frame: Adverse Events were monitored for 14 weeks (Screening period, up to 4 weeks; 3-period crossover, up to 8 weeks; End of Study Evaluation, 2 weeks post crossover period).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A: AD109	1 of 56 (1.8%)	2 of 56 (3.6%)	0 of 56
B: Atomoxetine 75 mg + Placebo	0 of 54 (0%)	2 of 54 (3.7%)	0 of 54
C: R-oxybutynin 2.5 mg + Placebo	0 of 54 (0%)	0 of 54 (0%)	0 of 54
D:Placebo + Placebo	0 of 57 (0%)	0 of 57 (0%)	0 of 57

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AD109, Atomoxetine and R-oxybutynin in people with Obstructive Sleep Apnea, run by Apnimed at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour] (time frame: 1 night (treatment duration) (0-8 hours collected continuously)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04580394.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.