Obstructive Sleep ApneaPhase 2NCT04645524
Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea
A Phase 2 study testing AD182, AD504 and Polysomnography in people with Obstructive Sleep Apnea, run by Apnimed at 1 site in United States.
Trial summary
This is a randomized, 3-period, placebo-controlled, crossover study to examine the efficacy and safety of AD182 and AD504 versus 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?
- AD182, AD504 and Polysomnography
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 1 Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 and 65 years of age, inclusive, at the time of the screening visit
- AHI 10 to 55 events/h 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
1 site in 1 country.
About this study
Official title: Phase 2 Randomized, Double Blind, Placebo-Controlled, Single-Dose, 3-Period Crossover Study to Evaluate the Efficacy of AD182, and AD504 in Obstructive Sleep Apnea
This is a randomized, 3-period, placebo-controlled, crossover study to examine the efficacy and safety of AD182 and AD504 versus placebo in patients with obstructive sleep apnea.
Read the detailed description
The study is designed to examine the efficacy and safety of AD182 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 3 treatments: AD182, AD504, or Placebo. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- AD182, AD504, Placebo, Polysomnography
- 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.
AD182Drug
Oral capsule administered before bed
AD504Drug
Oral capsule administered before bed
PlaceboDrug
Oral capsule administered before bed
PolysomnographyDiagnostic test
for all arms
| Study group | Role | What they receive |
|---|---|---|
| AD182 | Experimental | Oral capsule administered before bed Receives: Drug: AD182; Diagnostic Test: Polysomnography |
| AD504 | Experimental | Oral capsule administered before bed Receives: Drug: AD504; Diagnostic Test: Polysomnography |
| Placebo | Placebo comparator | Oral capsule administered before bed Receives: Drug: Placebo; Diagnostic Test: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)
Apnea-Hypopnea Index, AD182 and AD504 vs placebo
Measured: 1 night (treatment duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start1 Dec 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apnimed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Corser, MD, Principal investigator, Intrepid Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645524
- Sponsor's protocol ID
- APX-001
- Status last verified
- Aug 2022
- First submitted
- 21 Nov 2020
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Corser B, Eves E, Warren-McCormick J, Rucosky G. Effects of atomoxetine plus a hypnotic on obstructive sleep apnea severity in patients with a moderately collapsible pharyngeal airway. J Clin Sleep Med. 2023 Jun 1;19(6):1035-1042. doi: 10.5664/jcsm.10464.
PubMed 36734173
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized, Double Blind, Placebo-Controlled, Single-Dose, 3-Period Crossover Study to Evaluate the Efficacy of AD182, and AD504 in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04645524
- Acronym / sponsor ID
- APX-001
- Conditions
- Obstructive Sleep Apnea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ApnimedIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
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, 3-period, placebo-controlled, crossover study to examine the efficacy and safety of AD182 and AD504 versus placebo in patients with obstructive sleep apnea.
Detailed description
The study is designed to examine the efficacy and safety of AD182 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 3 treatments: AD182, AD504, or Placebo. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.
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 |
|---|---|---|
| AD182 | Experimental | Drug: AD182, Diagnostic Test: PolysomnographyOral capsule administered before bed |
| AD504 | Experimental | Drug: AD504, Diagnostic Test: PolysomnographyOral capsule administered before bed |
| Placebo | Placebo comparator | Drug: Placebo, Diagnostic Test: PolysomnographyOral capsule administered before bed |
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 and 65 years of age, inclusive, at the time of the screening visit
- AHI 10 to 55 events/h 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 |
|---|---|---|
| AD182Oral capsule administered before bed | Drug | AD182 |
| AD504Oral capsule administered before bed | Drug | AD504 |
| PlaceboOral capsule administered before bed | Drug | Placebo |
| Polysomnographyfor all arms | Diagnostic test | AD182, AD504, Placebo |
Primary outcome
Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)
Time frame: 1 night (treatment duration)
Apnea-Hypopnea Index, AD182 and AD504 vs placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Derived from this study: PubMed 36734173Corser B, Eves E, Warren-McCormick J, Rucosky G. Effects of atomoxetine plus a hypnotic on obstructive sleep apnea severity in patients with a moderately collapsible pharyngeal airway. J Clin Sleep Med. 2023 Jun 1;19(6):1035-1042. doi: 10.5664/jcsm.10464.
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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.
Bruce Corser, MD principal investigator
Intrepid Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AD182, AD504 and Polysomnography in people with Obstructive Sleep Apnea, run by Apnimed at 1 site 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 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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, average number of events for every hour of sleep) (time frame: 1 night (treatment duration)). 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 NCT04645524, 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 2 Sep 2022.