Trial Outcomes & Findings for DAW1033B2 in Obstructive Sleep Apnea (NCT NCT03426631)

Last Updated: 2020-02-19

Results Overview

Based on previous studies the investigators anticipate that DAW1032B2 will reduce AHI more effectively in subjects with moderate sleep apnea, mildly obese (BMI\<32), Vpassive \> 50% of Veupnea (ventilation during eupneic ventilatory drive)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

1 night

Results posted on

2020-02-19

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo First, DAW1033B2 Second Placebo-matching DAW1033B2 administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then DAW1033B2 administered 30 mins before normal sleep time on second study night.	DAW1033B2 First, Placebo Second DAW1033B2 administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then placebo administered 30 mins before normal sleep time on second study night.
Overall Study STARTED	7	6
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo First, DAW1033B2 Second Placebo-matching DAW1033B2 administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then DAW1033B2 administered 30 mins before normal sleep time on second study night.	DAW1033B2 First, Placebo Second DAW1033B2 administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then placebo administered 30 mins before normal sleep time on second study night.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

DAW1033B2 in Obstructive Sleep Apnea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Analyzed Participants n=12 Participants All participants who were randomized, completed both study nights, and were included in the analysis.
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 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	4 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 night

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo before sleep Placebo oral capsule: Placebo capsule 30 minutes before sleep	DAW1033B2 Oral Capsule n=12 Participants DAW1033B2 before sleep DAW1033B2 oral capsule: DAW1033B2 capsule 30 minutes before sleep
Apnea Hypopnea Index (AHI, Events/Hour of Sleep)	33 events/hour of sleep Interval 24.1 to 41.9	20.4 events/hour of sleep Interval 6.4 to 47.9

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DAW1033B2 Oral Capsule

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=12 participants at risk Placebo before sleep Placebo oral capsule: Placebo capsule 30 minutes before sleep	DAW1033B2 Oral Capsule n=12 participants at risk DAW1033B2 before sleep DAW1033B2 oral capsule: DAW1033B2 capsule 30 minutes before sleep
Gastrointestinal disorders Heartburn (gastroesophageal reflux)	0.00% 0/12 • 1 night	8.3% 1/12 • Number of events 1 • 1 night

Additional Information

Luigi Taranto Montemurro, MD

Brigham and Women's Hospital

Phone: 6177326541

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place