OSA - Obstructive Sleep Apnea
Conditions
Brief summary
This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.
Interventions
Sponsors
Apnimed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Between 18 to 65 years of age for men and 18-75 for women, inclusive, at the Screening Visit. * Mean AHI 10 to 45 events/h, inclusive * PGI-S: \>1 * BMI between 18.5 and 38 kg/m2 for men and 40 kg/m2 for women, inclusive.
Exclusion criteria
* Current clinically significant sleep disorder other than OSA * Clinically significant craniofacial malformation. * Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control). * Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first PSG and are not used during participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD109 Arms vs. Placebo | Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6) | Change in AHI4 (apnea-hypopnea index, 4% oxygen desaturation criterion; average respiratory events per hour of sleep) measured by in-lab polysomnography. Baseline was the mean of two pre-treatment PSG nights (Visits 2 and 3). Change from baseline was assessed at treatment PSG nights at approximately Day 21 (Visit 5) and Day 28 (Visit 6), modeled as repeated measures, with the reported value representing the model-based LS mean using equal (0.5/0.5) weighting between the Day 21 and Day 28 visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD504 Arms vs. Placebo | Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6) | Change in AHI4 (apnea-hypopnea index, 4% oxygen desaturation criterion; average respiratory events per hour of sleep) measured by in-lab polysomnography. Baseline was the mean of two pre-treatment PSG nights (Visits 2 and 3). Change from baseline was assessed at treatment PSG nights at approximately Day 21 (Visit 5) and Day 28 (Visit 6), modeled as repeated measures, with the reported value representing the model-based LS mean using equal (0.5/0.5) weighting between the Day 21 and Day 28 visits. |
| Change in Apnea-Hypopnea Index (AHI4) From Baseline: Atomoxetine vs. Placebo | Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6) | Change in AHI4 (apnea-hypopnea index, 4% oxygen desaturation criterion; average respiratory events per hour of sleep) measured by in-lab polysomnography. Baseline was the mean of two pre-treatment PSG nights (Visits 2 and 3). Change from baseline was assessed at treatment PSG nights at approximately Day 21 (Visit 5) and Day 28 (Visit 6), modeled as repeated measures, with the reported value representing the model-based LS mean using equal (0.5/0.5) weighting between the Day 21 and Day 28 visits. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 30 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age, Continuous | 54.2 years STANDARD_DEVIATION 9.49 |
| Body Mass Index (BMI) | 31.16 kg/m2 STANDARD_DEVIATION 4.716 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 41 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 226 Participants |
| Region of Enrollment United States | 292 participants |
| Sex: Female, Male Female | 121 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 42 | 0 / 43 | 0 / 40 | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 32 / 41 | 26 / 42 | 33 / 43 | 24 / 40 | 51 / 63 | 25 / 63 |
| serious Total, serious adverse events | 0 / 41 | 0 / 42 | 0 / 43 | 0 / 40 | 0 / 63 | 0 / 63 |
Outcome results
None listed