OSAPhase 2VicTorNCT05793684

AD816 Crossover Study

A Phase 2 study testing Period A, Period B and Period C in people with OSA and Obstructive Sleep Apnea, run by Apnimed at 3 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

The VicTor Study is a randomized, double blind, placebo-controlled, 3-period, multiple-dose crossover study in participants with OSA. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: OSA, Obstructive Sleep Apnea
What is being tested?: Period A, Period B and Period C
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 3 sitesUnited States
Study dates: 28 Apr 2023to 9 Nov 2023
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Between 18 to 75 years of age, inclusive, at the Screening Visit
PSG criteria (V2 only)
AHI4 (Hypopneas defined by 4% oxygen desaturation) of 10-45, inclusive
≤25% of events are central or mixed apneas
PROMIS Fatigue or sleep related impairment or sleep disturbance (raw score): >11, i.e. at least "very mild symptoms" at V1
BMI between 18.5 and 40 kg/m2, inclusive

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Male participants:
If sexually active with female partner(s) of childbearing potential, participant must agree, from Study Day 1 through 1 week after the last dose of study drug, to practice the protocol specified contraception
Female participants:
If of childbearing potential (WOCBP), the participant must agree, from Study Day 1 through 1 week after the last dose of study drug, to practice the protocol specified contraception. All WOCBP must have negative result of a serum pregnancy test performed at screening.
Females of non-childbearing potential include postmenopausal (defined as age ≥ 55 years with no menses for 12 or more months without an alternative medical cause) or permanently sterile (e.g. bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the Screening Visit procedures.
Participant must be able to understand the nature of the study and must have the opportunity to have any questions answered

Who cannot join

Current clinically significant sleep disorder other than OSA of a severity that would interfere with study participation or interpretability of data.
Clinically significant craniofacial malformation or grade ≥3 tonsillar hypertrophy.
Current clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or poorly controlled hypertension (>140/90mmHg).
Long QT syndrome or family history of long QT syndrome
Current clinically significant neurological disorder, including epilepsy/convulsions.
Other active major organ system disease including renal failure, lung disease, neuromuscular disease, or liver disease.

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Schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) or International Classification of Disease tenth edition criteria.
Attempted suicide within 1 year prior to screening, or current suicidal ideation.
Clinically significant urinary retention, gastric retention or other severe decreased gastrointestinal motility condition.
Benign prostatic hypertrophy that is actively being treated with alpha-1 adrenergic antagonist
Severe or frequent gastroesophageal reflux or constipation
Medically unexplained positive screen for drugs of abuse (excluding THC/marijuana) or history of substance use disorder as defined in DSM-V within 24 months prior to Screening Visit.
A serious illness or infection in the past 30 days as determined by investigator.
Clinically significant cognitive dysfunction as determined by investigator.
Untreated narrow angle glaucoma.
Women who are pregnant or nursing.
CPAP should not be used for at least 2 weeks prior to first study PSG and during entire participation in the study.
History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used for at least 2 weeks prior to first study PSG and 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 for at least 2 weeks prior to first study PSG and during participation in the study.
Chronic oxygen therapy.
Patients with hypoglossal nerve stimulation implant. Prior/Concurrent Clinical Study Experience
Use of another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to dosing.
Prolonged QT interval (> 450 ms in men or > 470 ms in women, after correction with most appropriate formula for observed heart rate), hypokalemia or hypomagnesemia (defined as >0.1 mEq/L below lower limit of normal for the testing laboratory).
Hepatic transaminases >2X the upper limit of normal (ULN), total bilirubin >1.5X ULN (unless confirmed Gilbert syndrome), estimated glomerular filtration rate < 50 ml/min.
Night- or shift-work sleep schedule which causes the major sleep period to be during the day, or planned travel across more than 1 time zone during the anticipated enrollment period
Employment as a commercial driver or operator of hazardous equipment.
Typically smoking more than 10 cigarettes or 2 cigars per day (or equivalent Vaping), or inability to abstain from smoking during overnight PSG visits.
Unwilling to use specified contraception.
History of regular alcohol consumption of more than 14 standard units per week (males) or more than 7 standard units per week (females), or unwillingness to limit alcohol consumption to no greater than 2 units/day (males), 1 unit per day (females). Alcohol is not to be consumed within 3 hours of bedtime or on PSG nights.
Unwilling to agree to limit during the study period caffeinated beverage intake (e.g., coffee, cola, tea) to 200 mg/day or less of caffeine, not to be used within 3 hours of bedtime. Viloxazine may increase the duration of effect of caffeine.
Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
Participant considered by the investigator, for any reason, an unsuitable candidate to receive viloxazine or AD816 components, or unable or unlikely to understand or comply with the dosing schedule or study evaluations.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Brigham and Women's Hospital
Boston, Massachusetts, 02115
Santa Monica Clinical Trials
Los Angeles, California, 90025
Clayton Sleep Institute
St Louis, Missouri, 63143

Other trials in United States

About this study

Official title: Phase 2 Randomized Double-Blind Placebo-Controlled Multiple-Dose 3-Period Crossover Study to Compare a Fixed Dose Combination of AD816 to Viloxazine Alone and to Placebo in Obstructive Sleep Apnea

The VicTor Study is a randomized, double blind, placebo-controlled, 3-period, multiple-dose crossover study in participants with OSA.

Conditions: OSA, Obstructive Sleep Apnea
Being tested: Period A, Period B, Period C
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.

Period ADrug
Week 1: Viloxazine low dose + placebo; Week 2: Viloxazine high dose + placebo
Period BDrug
Week 1: AD816 low dose; Week 2: AD816 high dose
Period CDrug
Week 1: Placebo + Placebo; Week 2: Placebo + Placebo

Study groups in NCT05793684
Study group	Role	What they receive
Order: Period A, Period B, Period C	Experimental	The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week). Receives: Drug: Period A; Drug: Period B; Drug: Period C
Order: Period B, Period C, Period A	Experimental	The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week). Receives: Drug: Period A; Drug: Period B; Drug: Period C
Order: Period C, Period A, Period B	Experimental	The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week). Receives: Drug: Period A; Drug: Period B; Drug: Period C
Order: Period A, Period C, Period B	Experimental	The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week). Receives: Drug: Period A; Drug: Period B; Drug: Period C
Order: Period B, Period A, Period C	Experimental	The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week). Receives: Drug: Period A; Drug: Period B; Drug: Period C
Order: Period C, Period B, Period A	Experimental	The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week). Receives: Drug: Period A; Drug: Period B; Drug: Period C

What is being measured

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

Apnea-hypopnea index (AHI) 4%, AD816 vs. Placebo
Apnea-hypopnea index based on 4% hypopnea desaturation
Measured: 14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm)

Timeline

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

28 Apr 20239 Nov 2023

First posted31 Mar 2023
Study start28 Apr 2023
Primary completion9 Nov 2023
Study completion9 Nov 2023

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 OSAStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05793684
Sponsor's protocol ID: APV-001
Acronym: VicTor
Status last verified: Nov 2023
First submitted: 18 Mar 2023
Last updated: 15 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Aishah A, Kim M, Gell L, Vena D, Azarbarzin A, Pho H, Norman D, Ojile J, Esmaeili N, Taranto-Montemurro L, Wellman A, Sands S, Messineo L. Effect of viloxazine and trazodone in obstructive sleep apnoea: a randomised, placebo-controlled, cross-over study. Thorax. 2025 Aug 15;80(9):641-649. doi: 10.1136/thorax-2024-222513.
PubMed 40360261

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

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All OSA trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Randomized Double-Blind Placebo-Controlled Multiple-Dose 3-Period Crossover Study to Compare a Fixed Dose Combination of AD816 to Viloxazine Alone and to Placebo in Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT05793684
Acronym / sponsor ID: VicTor / APV-001
Conditions: OSA, Obstructive Sleep Apnea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: ApnimedIndustry (pharma, biotech, devices)
Study start: 28 Apr 2023 (actual)
Primary completion: 9 Nov 2023 (actual)
Study completion: 9 Nov 2023 (actual)
First posted: 31 Mar 2023 (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.

The VicTor Study is a randomized, double blind, placebo-controlled, 3-period, multiple-dose crossover study in participants with OSA.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Order: Period A, Period B, Period C	Experimental	Drug: Period A, Drug: Period B, Drug: Period CThe sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Order: Period B, Period C, Period A	Experimental	Drug: Period A, Drug: Period B, Drug: Period CThe sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Order: Period C, Period A, Period B	Experimental	Drug: Period A, Drug: Period B, Drug: Period CThe sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Order: Period A, Period C, Period B	Experimental	Drug: Period A, Drug: Period B, Drug: Period CThe sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Order: Period B, Period A, Period C	Experimental	Drug: Period A, Drug: Period B, Drug: Period CThe sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Order: Period C, Period B, Period A	Experimental	Drug: Period A, Drug: Period B, Drug: Period CThe sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Between 18 to 75 years of age, inclusive, at the Screening Visit
PSG criteria (V2 only)
PROMIS Fatigue or sleep related impairment or sleep disturbance (raw score): >11, i.e. at least "very mild symptoms" at V1
BMI between 18.5 and 40 kg/m2, inclusive
If sexually active with female partner(s) of childbearing potential, participant must agree, from Study Day 1 through 1 week after the last dose of study drug, to practice the protocol specified contraception

Key exclusion criteria (32 listed)

Current clinically significant sleep disorder other than OSA of a severity that would interfere with study participation or interpretability of data.
Clinically significant craniofacial malformation or grade ≥3 tonsillar hypertrophy.
Current clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or poorly controlled hypertension (>140/90mmHg).
Long QT syndrome or family history of long QT syndrome
Current clinically significant neurological disorder, including epilepsy/convulsions.

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
Period AWeek 1: Viloxazine low dose + placebo; Week 2: Viloxazine high dose + placebo	Drug	Order: Period A, Period B, Period C, Order: Period A, Period C, Period B, Order: Period B, Period A, Period C, Order: Period B, Period C, Period A, Order: Period C, Period A, Period B, Order: Period C, Period B, Period A
Period BWeek 1: AD816 low dose; Week 2: AD816 high dose	Drug	Order: Period A, Period B, Period C, Order: Period A, Period C, Period B, Order: Period B, Period A, Period C, Order: Period B, Period C, Period A, Order: Period C, Period A, Period B, Order: Period C, Period B, Period A
Period CWeek 1: Placebo + Placebo; Week 2: Placebo + Placebo	Drug	Order: Period A, Period B, Period C, Order: Period A, Period C, Period B, Order: Period B, Period A, Period C, Order: Period B, Period C, Period A, Order: Period C, Period A, Period B, Order: Period C, Period B, Period A

Primary outcome

Apnea-hypopnea index (AHI) 4%, AD816 vs. Placebo
Time frame: 14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm)
Apnea-hypopnea index based on 4% hypopnea desaturation

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 15 Nov 2023.
Derived from this study: PubMed 40360261Aishah A, Kim M, Gell L, Vena D, Azarbarzin A, Pho H, Norman D, Ojile J, Esmaeili N, Taranto-Montemurro L, Wellman A, Sands S, Messineo L. Effect of viloxazine and trazodone in obstructive sleep apnoea: a randomised, placebo-controlled, cross-over study. Thorax. 2025 Aug 15;80(9):641-649. doi: 10.1136/thorax-2024-222513.
Individual participant dataSharing planned: No

Related trials for OSA

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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.

Ronald Farkas, MD study director

Apnimed Inc.

3 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 Period A, Period B and Period C in people with OSA and Obstructive Sleep Apnea, run by Apnimed at 3 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 13 inclusion and 32 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 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. 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) 4%, AD816 vs. Placebo (time frame: 14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm)). 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 NCT05793684, 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 15 Nov 2023.