Trial Outcomes & Findings for AD109 Dose Finding in Mild to Moderate OSA (NCT NCT04631107)
NCT ID: NCT04631107
Last Updated: 2022-12-22
Results Overview
Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Due to the known logarithmic distribution of HB, data are primarily expressed and analyzed as Log10HB 4%\[% min/h\]. Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
1 night (8 hours)
Results posted on
2022-12-22
Participant Flow
A total of 65 participants were screened in the study. Thirty-two participants were randomized.
Participants who met all enrollment criteria were planned to be randomized to receive the following oral experimental treatments, 1 treatment on each of 3 PSG nights, separated by at least a 1 week washout period. One ineligible participant was inadvertently randomized but not treated. Twenty-seven participants completed the study. Four participants were treated but early terminated from the study.
Participant milestones
| Measure |
All Participants
There were three periods with treatment assigned in random order. Treatment A-AD109 dose1 75mg, Treatment B- AD109 37.5 mg, and Treatment C- Placebo. Administered orally at bedtime.
|
|---|---|
|
First Intervention (1 Night)
STARTED
|
32
|
|
First Intervention (1 Night)
Treatment A
|
11
|
|
First Intervention (1 Night)
Treatment B
|
9
|
|
First Intervention (1 Night)
Treatment C
|
11
|
|
First Intervention (1 Night)
COMPLETED
|
31
|
|
First Intervention (1 Night)
NOT COMPLETED
|
1
|
|
Washout 1 Week
STARTED
|
31
|
|
Washout 1 Week
COMPLETED
|
31
|
|
Washout 1 Week
NOT COMPLETED
|
0
|
|
Second Intervention (1 Night)
STARTED
|
31
|
|
Second Intervention (1 Night)
Treatment A
|
11
|
|
Second Intervention (1 Night)
Treatment B
|
9
|
|
Second Intervention (1 Night)
Treatment C
|
9
|
|
Second Intervention (1 Night)
COMPLETED
|
29
|
|
Second Intervention (1 Night)
NOT COMPLETED
|
2
|
|
Washout-1 Week
STARTED
|
29
|
|
Washout-1 Week
COMPLETED
|
29
|
|
Washout-1 Week
NOT COMPLETED
|
0
|
|
Third Intervention (1 Night)
STARTED
|
29
|
|
Third Intervention (1 Night)
Treatment A
|
8
|
|
Third Intervention (1 Night)
Treatment B
|
10
|
|
Third Intervention (1 Night)
Treatment C
|
9
|
|
Third Intervention (1 Night)
COMPLETED
|
27
|
|
Third Intervention (1 Night)
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
All Participants
There were three periods with treatment assigned in random order. Treatment A-AD109 dose1 75mg, Treatment B- AD109 37.5 mg, and Treatment C- Placebo. Administered orally at bedtime.
|
|---|---|
|
First Intervention (1 Night)
ineligible participant was inadvertently randomized but not treated
|
1
|
|
Second Intervention (1 Night)
Adverse Event
|
1
|
|
Second Intervention (1 Night)
Withdrawal by Subject
|
1
|
|
Third Intervention (1 Night)
Withdrawal by Subject
|
2
|
Baseline Characteristics
AD109 Dose Finding in Mild to Moderate OSA
Baseline characteristics by cohort
| Measure |
All Participants
n=31 Participants
AD109 dose1 75mg, AD109 Dose 2 37.5 mg, and Placebo: Oral administration at bedtime, randomly sequence of all three study products.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
|
Hypoxic Burden (HB)
|
11.8 (%*min)/hour
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 night (8 hours)Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Due to the known logarithmic distribution of HB, data are primarily expressed and analyzed as Log10HB 4%\[% min/h\]. Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.
Outcome measures
| Measure |
AD109 dose1 vs Placebo
n=27 Participants
AD109 dose1 75mg: Oral administration at bedtime
|
AD109 dose2 vs Placebo
n=27 Participants
AD109 dose2 37.5mg: Oral administration at bedtime
|
Dose 2 vs Dose 1
n=27 Participants
Low Dose AD109 Versus High Dose AD109
|
|---|---|---|---|
|
Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h]
|
-0.40 difference in log10HB[(%*min)/h]
Interval -0.54 to -0.25
|
-0.21 difference in log10HB[(%*min)/h]
Interval -0.36 to -0.07
|
0.18 difference in log10HB[(%*min)/h]
Interval 0.04 to 0.33
|
PRIMARY outcome
Timeframe: 1 night (8 hours)Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.
Outcome measures
| Measure |
AD109 dose1 vs Placebo
n=27 Participants
AD109 dose1 75mg: Oral administration at bedtime
|
AD109 dose2 vs Placebo
n=27 Participants
AD109 dose2 37.5mg: Oral administration at bedtime
|
Dose 2 vs Dose 1
n=27 Participants
Low Dose AD109 Versus High Dose AD109
|
|---|---|---|---|
|
Change in Hypoxic Burden (HB) Raw Values - HB[(%*Min)/h]
|
-6.90 (%*min)/h
Interval -10.2 to -3.6
|
-4.70 (%*min)/h
Interval -8.01 to -1.38
|
2.20 (%*min)/h
Interval -1.23 to 5.36
|
Adverse Events
AD109 dose1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AD109 dose2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AD109 dose1
n=30 participants at risk
AD109 dose1 75mg: Oral administration at bedtime
|
AD109 dose2
n=28 participants at risk
AD109 dose2 37.5mg: Oral administration at bedtime
|
Placebo
n=29 participants at risk
Placebo: Oral administration at bedtime
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
2/30 • Number of events 2 • Adverse Events were collected for each subject for up to 12 weeks. The overall study duration was up to 12 weeks (Screening period, up to 4 weeks; 3-period crossover, up to 6 weeks; End of Study Evaluation, 2 weeks post crossover period).
The definition of adverse events is the same as clinicaltrials.gov. All AE and SAE were collected from the signing of the informed consent form (ICF) until the end of the study at the timepoints specified in the schedule of assessments
|
3.6%
1/28 • Number of events 1 • Adverse Events were collected for each subject for up to 12 weeks. The overall study duration was up to 12 weeks (Screening period, up to 4 weeks; 3-period crossover, up to 6 weeks; End of Study Evaluation, 2 weeks post crossover period).
The definition of adverse events is the same as clinicaltrials.gov. All AE and SAE were collected from the signing of the informed consent form (ICF) until the end of the study at the timepoints specified in the schedule of assessments
|
0.00%
0/29 • Adverse Events were collected for each subject for up to 12 weeks. The overall study duration was up to 12 weeks (Screening period, up to 4 weeks; 3-period crossover, up to 6 weeks; End of Study Evaluation, 2 weeks post crossover period).
The definition of adverse events is the same as clinicaltrials.gov. All AE and SAE were collected from the signing of the informed consent form (ICF) until the end of the study at the timepoints specified in the schedule of assessments
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
2/30 • Number of events 2 • Adverse Events were collected for each subject for up to 12 weeks. The overall study duration was up to 12 weeks (Screening period, up to 4 weeks; 3-period crossover, up to 6 weeks; End of Study Evaluation, 2 weeks post crossover period).
The definition of adverse events is the same as clinicaltrials.gov. All AE and SAE were collected from the signing of the informed consent form (ICF) until the end of the study at the timepoints specified in the schedule of assessments
|
0.00%
0/28 • Adverse Events were collected for each subject for up to 12 weeks. The overall study duration was up to 12 weeks (Screening period, up to 4 weeks; 3-period crossover, up to 6 weeks; End of Study Evaluation, 2 weeks post crossover period).
The definition of adverse events is the same as clinicaltrials.gov. All AE and SAE were collected from the signing of the informed consent form (ICF) until the end of the study at the timepoints specified in the schedule of assessments
|
0.00%
0/29 • Adverse Events were collected for each subject for up to 12 weeks. The overall study duration was up to 12 weeks (Screening period, up to 4 weeks; 3-period crossover, up to 6 weeks; End of Study Evaluation, 2 weeks post crossover period).
The definition of adverse events is the same as clinicaltrials.gov. All AE and SAE were collected from the signing of the informed consent form (ICF) until the end of the study at the timepoints specified in the schedule of assessments
|
|
General disorders
Thirst
|
0.00%
0/30 • Adverse Events were collected for each subject for up to 12 weeks. The overall study duration was up to 12 weeks (Screening period, up to 4 weeks; 3-period crossover, up to 6 weeks; End of Study Evaluation, 2 weeks post crossover period).
The definition of adverse events is the same as clinicaltrials.gov. All AE and SAE were collected from the signing of the informed consent form (ICF) until the end of the study at the timepoints specified in the schedule of assessments
|
3.6%
1/28 • Number of events 1 • Adverse Events were collected for each subject for up to 12 weeks. The overall study duration was up to 12 weeks (Screening period, up to 4 weeks; 3-period crossover, up to 6 weeks; End of Study Evaluation, 2 weeks post crossover period).
The definition of adverse events is the same as clinicaltrials.gov. All AE and SAE were collected from the signing of the informed consent form (ICF) until the end of the study at the timepoints specified in the schedule of assessments
|
6.9%
2/29 • Number of events 2 • Adverse Events were collected for each subject for up to 12 weeks. The overall study duration was up to 12 weeks (Screening period, up to 4 weeks; 3-period crossover, up to 6 weeks; End of Study Evaluation, 2 weeks post crossover period).
The definition of adverse events is the same as clinicaltrials.gov. All AE and SAE were collected from the signing of the informed consent form (ICF) until the end of the study at the timepoints specified in the schedule of assessments
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place