Obstructive Sleep ApneaPhase 2NCT04445688

Crossover Trial of AD036 in Obstructive Sleep Apnea

A Phase 2 study testing AD036 and Atomoxetine in people with Obstructive Sleep Apnea, run by Apnimed at 5 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, 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. 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?: AD036 and Atomoxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 62 participants
Where: 5 sitesUnited States
Study dates: 15 Jul 2020to 1 Dec 2020
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 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

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Sleep Medicine & Research Center, St. Luke's Hospital
Chesterfield, Missouri, 63017
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
SDS Clinical Trials, Inc.
Santa Ana, California, 92705

Other trials in United States

About this study

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

Read the 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.

Conditions: Obstructive Sleep Apnea
Being tested: AD036, Atomoxetine, Placebo
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.

AD036Drug
Oral administration before bed
AtomoxetineDrug
Oral administration before bed
PlaceboDrug
Oral administration before bed

Study groups in NCT04445688
Study group	Role	What they receive
AD036	Experimental	AD036 oral capsule administered before sleep Receives: Drug: AD036
Atomoxetine	Active comparator	Atomoxetine oral capsule administered before sleep Receives: Drug: Atomoxetine
Placebo	Placebo comparator	Placebo oral capsule administered before sleep Receives: Drug: Placebo

What is being measured

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

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
Measured: 1 day

Secondary outcomes (2)

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
Measured: 1 day
ODI
Oxygen Desaturation Index, measured by pulse-oximetry, AD036 vs. placebo
Measured: 1 day

Timeline

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

15 Jul 20201 Dec 2020

First posted24 Jun 2020
Study start15 Jul 2020
Primary completion1 Dec 2020
Study completion1 Dec 2020

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.
Publications (1)Papers the sponsor has linked to this study.
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: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04445688
Sponsor's protocol ID: APN-006
Status last verified: Sep 2023
First submitted: 19 Jun 2020
Last updated: 14 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 35551600

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 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04445688
Acronym / sponsor ID: APN-006
Conditions: Obstructive Sleep Apnea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: ApnimedIndustry (pharma, biotech, devices)
Study start: 15 Jul 2020 (actual)
Primary completion: 1 Dec 2020 (actual)
Study completion: 1 Dec 2020 (actual)
First posted: 24 Jun 2020 (actual)
Results: Posted 21 Aug 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: 3

Arm	Type	Receives
AD036	Experimental	Drug: AD036AD036 oral capsule administered before sleep
Atomoxetine	Active comparator	Drug: AtomoxetineAtomoxetine oral capsule administered before sleep
Placebo	Placebo comparator	Drug: PlaceboPlacebo oral 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 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
AD036Oral administration before bed	Drug	AD036
AtomoxetineOral administration before bed	Drug	Atomoxetine
PlaceboOral administration before bed	Drug	Placebo

Primary outcome

Apnea-Hypopnea Index
Time frame: 1 day
Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo

2 secondary outcomes

Hypoxic Burden
Time frame: 1 day
ODI
Time frame: 1 day

Results and safety

Results posted to the registry on 21 Aug 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	62	62

Primary outcome: Apnea-Hypopnea Index

Time frame: 1 day. Least squares mean (95% Confidence Interval). Unit: events/hour

Measure	AD036 n = 54	Atomoxetine n = 56	Placebo n = 57
Value	11.5 (7.2 to 15.8)	11.5 (7.2 to 15.8)	18.8 (14.5 to 23.1)

AD036 vs Placebo: difference in Least Squares Mean: -7.3 (95% CI -10.2 to -4.4), p <0.0001, ANOVA

Population analysed: The efficacy was analyzed using the mITT Population comprised of all participants who took at least 1 dose of any of the study treatments and had at least 1 measurement on the primary endpoint. Sixty (96.8%) patients were included in the mITT Population. Patients were analyzed for efficacy according to the treatment sequence into which they were randomized. Due to insufficient data quality of the home sleep test, AHI could not be determined in some treatment conditions.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AD036	0 of 59 (0%)	8 of 59 (13.6%)	0 of 59
Atomoxetine	0 of 62 (0%)	11 of 62 (17.7%)	0 of 62
Placebo	0 of 59 (0%)	5 of 59 (8.5%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35551600Schweitzer 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.

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.

5 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 AD036 and Atomoxetine in people with Obstructive Sleep Apnea, run by Apnimed at 5 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 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 21 Aug 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?

Apnea-Hypopnea Index (time frame: 1 day). 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 NCT04445688, which also lists 1 linked publication.

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 14 Sep 2023.