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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD036 | Experimental | AD036 oral capsule administered before sleep |
|
| Atomoxetine | Active Comparator | Atomoxetine oral capsule administered before sleep |
|
| Placebo | Placebo Comparator | Placebo oral capsule administered before sleep |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD036 | Drug | Oral administration before bed |
| |
| Atomoxetine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Preferred Research Partners, Inc. | Little Rock | Arkansas | 72211 | United States | ||
| SDS Clinical Trials, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35551600 | Result | 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. |
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All participants were centrally randomized to one of 6 sequences (A - B - C, B - C - A, C - B - A, A - C - B, B - A - C, C - A - B). A 1-week minimum washout period occurred between each of the 3 arm assignments.
5 clinical sites screened 101 participants 62 were randomized. This was an unblinded three period placebo controlled study. Participants who withdrew were not replaced.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | oral capsules administered before bedtime. Treatment A: AD036, Treatment B: atomoxetine + placebo, Treatment C: placebo + placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| ||||||||||||||||||||||
| Washout (One Week) |
| ||||||||||||||||||||||
| Second Intervention |
| ||||||||||||||||||||||
| Washout (One Week) |
| ||||||||||||||||||||||
| Third Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | oral capsules administered before bedtime. Treatment A: AD036, Treatment B: atomoxetine + placebo, Treatment C: placebo + placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | Least Squares Mean | 95% Confidence Interval | events/hour | 1 day |
|
10 weeks
Planned time points for all adverse events assessments at each study visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AD036 | AD036 oral capsule administered before sleep AD036: Oral administration before bed |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials | Apnimed, Inc | 617-500-8880 | clinicaltrials@apnimed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 15, 2020 | Jun 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2020 | Jun 22, 2023 | SAP_001.pdf |
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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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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Drug |
Oral administration before bed |
|
| Placebo | Drug | Oral administration before bed |
|
| ODI |
Oxygen Desaturation Index, measured by pulse-oximetry, AD036 vs. placebo |
| 1 day |
| Santa Ana |
| California |
| 92705 |
| United States |
| The Center for Sleep and Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| Sleep Medicine & Research Center, St. Luke's Hospital | Chesterfield | Missouri | 63017 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
|
| Treatment C |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Treatment C |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI (kg/m^2) | Median | Full Range | kg/m^2 |
|
| OG001 |
| Atomoxetine |
Atomoxetine oral capsule administered before sleep Atomoxetine: Oral administration before bed |
| OG002 | Placebo | Placebo oral capsule administered before sleep Placebo: Oral administration before bed |
|
|
|
| Secondary | 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 | 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, hypoxic burden could not be determined in some treatment conditions. | Posted | Least Squares Mean | 95% Confidence Interval | %min/hour | 1 day |
|
|
|
|
| Secondary | ODI | Oxygen Desaturation Index, measured by pulse-oximetry, AD036 vs. placebo | 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. Mean (SD) of ODI (4%). Due to insufficient data quality of the home sleep test, ODI could not be determined in some treatment conditions. | Posted | Least Squares Mean | 95% Confidence Interval | events/hour | 1 day |
|
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 8 |
| 59 |
| EG001 | Atomoxetine | Atomoxetine oral capsule administered before sleep Atomoxetine: Oral administration before bed | 0 | 62 | 0 | 62 | 11 | 62 |
| EG002 | Placebo | Placebo oral capsule administered before sleep Placebo: Oral administration before bed | 0 | 59 | 0 | 59 | 5 | 59 |
| Insomnia | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |