drugset / Trial / NCT03426631

DAW1033B2 in Obstructive Sleep Apnea

NCT03426631 ↗

Phase 1/2 Completed 13 enrolled Brigham and Women's Hospital
RandomizedCrossoverQuadruple-blindTreatment

Summary

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of DAW1033B2 administered before sleep on OSA phenotype traits and OSA severity during sleep.

Timeline

Start
2017-09-15
Primary completion
2019-10-01
Completion
2020-01-20

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs DAW1033B2 Oral Capsule; p = 0.47; Median Difference (Final Values) -11.7; Wilcoxon (Mann-Whitney) NCT03426631 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject DAW1033B2 Unknown — Oral