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The VicTor Study is a randomized, double blind, placebo-controlled, 3-period, multiple-dose crossover study in participants with OSA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
|
| 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). |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Period A | Drug | Week 1: Viloxazine low dose + placebo; Week 2: Viloxazine high dose + placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea index (AHI) 4%, AD816 vs. Placebo | Apnea-hypopnea index based on 4% hypopnea desaturation | 14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm) |
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Inclusion Criteria:
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
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.
a. 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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Farkas, MD | Apnimed Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Monica Clinical Trials | Los Angeles | California | 90025 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40360261 | Derived | 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. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Double-blind study
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| 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). |
|
| 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). |
|
| Period B | Drug | Week 1: AD816 low dose; Week 2: AD816 high dose |
|
| Period C | Drug | Week 1: Placebo + Placebo; Week 2: Placebo + Placebo |
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Clayton Sleep Institute | St Louis | Missouri | 63143 | United States |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |