Trial Outcomes & Findings for Crossover Trial of AD036 in Obstructive Sleep Apnea (NCT NCT04445688)
NCT ID: NCT04445688
Last Updated: 2023-09-14
Results Overview
Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo
COMPLETED
PHASE2
62 participants
1 day
2023-09-14
Participant Flow
5 clinical sites screened 101 participants 62 were randomized. This was an unblinded three period placebo controlled study. Participants who withdrew were not replaced.
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.
Participant milestones
| Measure |
All Participants
oral capsules administered before bedtime. Treatment A: AD036, Treatment B: atomoxetine + placebo, Treatment C: placebo + placebo
|
|---|---|
|
First Intervention
STARTED
|
62
|
|
First Intervention
Treatment A
|
21
|
|
First Intervention
Treatment B
|
21
|
|
First Intervention
Treatment C
|
20
|
|
First Intervention
COMPLETED
|
62
|
|
First Intervention
NOT COMPLETED
|
0
|
|
Washout (One Week)
STARTED
|
59
|
|
Washout (One Week)
COMPLETED
|
59
|
|
Washout (One Week)
NOT COMPLETED
|
0
|
|
Second Intervention
STARTED
|
59
|
|
Second Intervention
Treatment A
|
18
|
|
Second Intervention
Treatment B
|
21
|
|
Second Intervention
Treatment C
|
20
|
|
Second Intervention
COMPLETED
|
59
|
|
Second Intervention
NOT COMPLETED
|
0
|
|
Third Intervention
STARTED
|
59
|
|
Third Intervention
Treatment A
|
20
|
|
Third Intervention
Treatment B
|
20
|
|
Third Intervention
Treatment C
|
19
|
|
Third Intervention
COMPLETED
|
59
|
|
Third Intervention
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
All Participants
oral capsules administered before bedtime. Treatment A: AD036, Treatment B: atomoxetine + placebo, Treatment C: placebo + placebo
|
|---|---|
|
Washout (One Week)
Adverse Event
|
2
|
|
Washout (One Week)
Withdrawal by Subject
|
1
|
Baseline Characteristics
Crossover Trial of AD036 in Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
All Participants
n=62 Participants
oral capsules administered before bedtime. Treatment A: AD036, Treatment B: atomoxetine + placebo, Treatment C: placebo + placebo
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
BMI (kg/m^2)
|
32.30 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: 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.
Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo
Outcome measures
| Measure |
AD036
n=54 Participants
AD036 oral capsule administered before sleep
AD036: Oral administration before bed
|
Atomoxetine
n=56 Participants
Atomoxetine oral capsule administered before sleep
Atomoxetine: Oral administration before bed
|
Placebo
n=57 Participants
Placebo oral capsule administered before sleep
Placebo: Oral administration before bed
|
|---|---|---|---|
|
Apnea-Hypopnea Index
|
11.5 events/hour
Interval 7.2 to 15.8
|
11.5 events/hour
Interval 7.2 to 15.8
|
18.8 events/hour
Interval 14.5 to 23.1
|
SECONDARY outcome
Timeframe: 1 dayPopulation: 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.
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
Outcome measures
| Measure |
AD036
n=54 Participants
AD036 oral capsule administered before sleep
AD036: Oral administration before bed
|
Atomoxetine
n=56 Participants
Atomoxetine oral capsule administered before sleep
Atomoxetine: Oral administration before bed
|
Placebo
n=57 Participants
Placebo oral capsule administered before sleep
Placebo: Oral administration before bed
|
|---|---|---|---|
|
Hypoxic Burden
|
24.3 %min/hour
Interval 13.5 to 35.1
|
26.8 %min/hour
Interval 16.1 to 37.6
|
46.1 %min/hour
Interval 35.4 to 56.8
|
SECONDARY outcome
Timeframe: 1 dayPopulation: 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.
Oxygen Desaturation Index, measured by pulse-oximetry, AD036 vs. placebo
Outcome measures
| Measure |
AD036
n=54 Participants
AD036 oral capsule administered before sleep
AD036: Oral administration before bed
|
Atomoxetine
n=56 Participants
Atomoxetine oral capsule administered before sleep
Atomoxetine: Oral administration before bed
|
Placebo
n=57 Participants
Placebo oral capsule administered before sleep
Placebo: Oral administration before bed
|
|---|---|---|---|
|
ODI
|
12.8 events/hour
Interval 8.4 to 17.1
|
13.3 events/hour
Interval 9.0 to 17.7
|
20.1 events/hour
Interval 15.8 to 24.4
|
Adverse Events
AD036
Atomoxetine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AD036
n=59 participants at risk
AD036 oral capsule administered before sleep
AD036: Oral administration before bed
|
Atomoxetine
n=62 participants at risk
Atomoxetine oral capsule administered before sleep
Atomoxetine: Oral administration before bed
|
Placebo
n=59 participants at risk
Placebo oral capsule administered before sleep
Placebo: Oral administration before bed
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.1%
3/59 • Number of events 3 • 10 weeks
Planned time points for all adverse events assessments at each study visit
|
6.5%
4/62 • Number of events 4 • 10 weeks
Planned time points for all adverse events assessments at each study visit
|
1.7%
1/59 • Number of events 1 • 10 weeks
Planned time points for all adverse events assessments at each study visit
|
|
Psychiatric disorders
Insomnia
|
8.5%
5/59 • Number of events 5 • 10 weeks
Planned time points for all adverse events assessments at each study visit
|
11.3%
7/62 • Number of events 7 • 10 weeks
Planned time points for all adverse events assessments at each study visit
|
6.8%
4/59 • Number of events 4 • 10 weeks
Planned time points for all adverse events assessments at each study visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place