Obstructive Sleep ApneaPhase 2NCT03845023
Trial of AD036 in Obstructive Sleep Apnea
A Phase 2 study testing AD036 Dose 1, AD036 Dose 2 and AD036 Dose 3 in people with Obstructive Sleep Apnea, run by Apnimed at 12 sites in United States.
Trial summary
This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels of AD036 versus placebo in patients with obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- AD036 Dose 1, AD036 Dose 2 and AD036 Dose 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 12 sitesUnited States
- Study dates
- 7 Mar 2019to 23 Oct 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHI ≥ 20 based on screening polysomnography
- Epworth Sleepiness Scale (ESS) score ≥ 4 for participants not using CPAP
- Previous surgical treatment for OSA is allowed if ≥ 1 year prior to enrollment
Who cannot join
- 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.
- Clinically significant neurological disorder, including epilepsy/convulsions.
- Positive screen for drugs of abuse or substance use disorder as defined in DSM-V within 24 months prior to Screening Visit.
- A significant illness or infection requiring medical treatment in the past 30 days.
- Women who are pregnant or nursing.
Show all 17Show fewer
- 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.
- History of using devices to affect participant sleeping position for the treatment of OSA, e.g. to discourage supine sleeping position, may enroll as long as the devices are not used during participation in the study.
- Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, strong cytochrome P450 2D6 (CYP2D6) inhibitors, or monoamine oxidase inhibitors (MAOI) within 14 days of the start of treatment, or concomitant with treatment.
- Use of another investigational agent within 90 days or 5 half-lives, whichever is longer, prior to dosing.
- ESS total score > 18.
- Central apnea index > 5/hour on baseline PSG.
- Periodic limb movement arousal index >15/hour on baseline PSG.
- Hepatic transaminases >3X the upper limit of normal (ULN), total bilirubin >2X ULN (unless confirmed Gilbert syndrome), serum creatinine >2X ULN.
- <6 hours typical sleep duration.
- Night- or shift-work sleep schedule.
- Employment as a commercial driver or operator of heavy or hazardous equipment.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Sleep Medicine & Research Center, St. Luke's Hospital
Chesterfield, Missouri, 63017
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815
Northwestern University
Chicago, Illinois, 60611
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Pulmonary Associates
Glendale, Arizona, 85306
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
Norton Clinical Research Group
Louisville, Kentucky, 40218
Clinilabs Drug Development Corporation
New York, New York, 10019
Stanford Sleep Medicine
Redwood City, California, 94063
Sleep Therapy & Research Center
San Antonio, Texas, 78229
SDS Clinical Trials, Inc.
Santa Ana, California, 92705
Santa Monica Clinical Trials
Santa Monica, California, 90404
About this study
Official title: Phase 2, Placebo-Controlled, Parallel Group Dose-Finding Study to Evaluate the Efficacy and Safety of Three Dose Levels of AD036 in Adults With Obstructive Sleep Apnea
This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels of AD036 versus placebo in patients with obstructive sleep apnea.
Read the detailed description
This was a randomized, double-blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient, multicenter, dose-finding study of the combination of atomoxetine and oxybutynin in adults with OSA documented by polysomnography (PSG).
Approximately 140 subjects were to be randomized 1:1:1:1 to receive 1 of 3 different fixed-dose combinations of oxybutynin and atomoxetine or matching placebo.
For all subjects, the study consisted of:
- A screening and baseline period in which subjects' eligibility was determined
- An initial 2-night, at-home blinded baseline period in which all subjects received placebo
- A 3-night, run-in period in which subjects received:
- Low-dose combination for subjects randomized to one of the 3 study treatment arms
- Placebo for subjects randomized to the placebo treatment arm
- A 7-night treatment period in which subjects received the treatment to which they were randomized, i.e., 1 of the 3 different fixed-dose combinations of drugs, or placebo
- An end of study visit
- Conditions
- Obstructive Sleep Apnea
- Being tested
- AD036 Dose 1, AD036 Dose 2, AD036 Dose 3, 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.
AD036 Dose 1Drug
Also called 25/5
AD036 Dose 1 oral capsule administered before sleep
AD036 Dose 2Drug
Also called 75/1.5
AD036 Dose 2 oral capsule administered before sleep
AD036 Dose 3Drug
Also called 75/5
AD036 Dose 3 oral capsule administered before sleep
PlaceboDrug
Placebo oral capsule administered before sleep
| Study group | Role | What they receive |
|---|---|---|
| 2-Night at Home | Placebo comparator | An initial 2-night, at-home blinded baseline period in which all subjects received placebo Receives: Drug: Placebo |
| 3-Night Run In | Experimental | AD036 Dose 1 (Low Dose: 25/5) or Placebo Receives: Drug: AD036 Dose 1; Drug: Placebo |
| 7-Night | Experimental | A 7-night treatment period in which subjects received the treatment to which they were randomized, i.e., 1 of the 3 different fixed-dose combinations of drugs, or placebo Receives: Drug: AD036 Dose 1; Drug: AD036 Dose 2; Drug: AD036 Dose 3; Drug: Placebo |
| End of Study | No intervention | End of Study Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI)
Number of participants with ≥50% reduction in apnea hypopnea index (AHI). AHI is the average number of apneas and hypopneas a person experiences each hour during sleep, to register as an event an apnea or hypopnea must last at least 10 seconds or longer. To measure this, doctors divide the total number of apneic and hypopneic events by the total number of hours the person was asleep.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start7 Mar 2019
- Primary completion23 Oct 2019
- Study completion23 Oct 2019
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apnimed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Farkas, MD, Study director, Apnimed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845023
- Sponsor's protocol ID
- APN-002
- Status last verified
- Nov 2022
- First submitted
- 15 Feb 2019
- Last updated
- 17 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Placebo-Controlled, Parallel Group Dose-Finding Study to Evaluate the Efficacy and Safety of Three Dose Levels of AD036 in Adults With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03845023
- Acronym / sponsor ID
- APN-002
- Conditions
- Obstructive Sleep Apnea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- ApnimedIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Posted 17 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels of AD036 versus placebo in patients with obstructive sleep apnea.
Detailed description
This was a randomized, double-blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient, multicenter, dose-finding study of the combination of atomoxetine and oxybutynin in adults with OSA documented by polysomnography (PSG).
Approximately 140 subjects were to be randomized 1:1:1:1 to receive 1 of 3 different fixed-dose combinations of oxybutynin and atomoxetine or matching placebo.
For all subjects, the study consisted of:
- A screening and baseline period in which subjects' eligibility was determined
- An initial 2-night, at-home blinded baseline period in which all subjects received placebo
- A 3-night, run-in period in which subjects received:
- Low-dose combination for subjects randomized to one of the 3 study treatment arms
- Placebo for subjects randomized to the placebo treatment arm
- A 7-night treatment period in which subjects received the treatment to which they were randomized, i.e., 1 of the 3 different fixed-dose combinations of drugs, or placebo
- An end of study visit
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2-Night at Home | Placebo comparator | Drug: PlaceboAn initial 2-night, at-home blinded baseline period in which all subjects received placebo |
| 3-Night Run In | Experimental | Drug: AD036 Dose 1, Drug: PlaceboAD036 Dose 1 (Low Dose: 25/5) or Placebo |
| 7-Night | Experimental | Drug: AD036 Dose 1, Drug: AD036 Dose 2, Drug: AD036 Dose 3, Drug: PlaceboA 7-night treatment period in which subjects received the treatment to which they were randomized, i.e., 1 of the 3 different fixed-dose combinations of drugs, or placebo |
| End of Study | No intervention | –End of Study Visit |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AHI ≥ 20 based on screening polysomnography
- Epworth Sleepiness Scale (ESS) score ≥ 4 for participants not using CPAP
- Previous surgical treatment for OSA is allowed if ≥ 1 year prior to enrollment
Key exclusion criteria (17 listed)
- 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.
- Clinically significant neurological disorder, including epilepsy/convulsions.
- Positive screen for drugs of abuse or substance use disorder as defined in DSM-V within 24 months prior to Screening Visit.
- A significant illness or infection requiring medical treatment in the past 30 days.
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 |
|---|---|---|
| AD036 Dose 1Also: 25/5AD036 Dose 1 oral capsule administered before sleep | Drug | 3-Night Run In, 7-Night |
| AD036 Dose 2Also: 75/1.5AD036 Dose 2 oral capsule administered before sleep | Drug | 7-Night |
| AD036 Dose 3Also: 75/5AD036 Dose 3 oral capsule administered before sleep | Drug | 7-Night |
| PlaceboPlacebo oral capsule administered before sleep | Drug | 2-Night at Home, 3-Night Run In, 7-Night |
Primary outcome
Apnea Hypopnea Index (AHI)
Time frame: 10 days
Number of participants with ≥50% reduction in apnea hypopnea index (AHI). AHI is the average number of apneas and hypopneas a person experiences each hour during sleep, to register as an event an apnea or hypopnea must last at least 10 seconds or longer. To measure this, doctors divide the total number of apneic and hypopneic events by the total number of hours the person was asleep.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ron Farkas, MD study director
Apnimed
12 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 Dose 1, AD036 Dose 2 and AD036 Dose 3 in people with Obstructive Sleep Apnea, run by Apnimed at 12 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 3 inclusion and 17 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 17 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 12 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 17 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?
Apnea Hypopnea Index (AHI) (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2023.