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Study for Efficacy and Dose Escalation of AD313 + Atomoxetine (SEED) — SEED  

Obstructive Sleep Apnea Clinical Trial

Official title:
Open-Label 4-Period Dose-Escalation Safety and Efficacy Study of AD313 in Participants With Obstructive Sleep Apnea

Clinical Trial Summary

The SEED study is designed to assess the safety and efficacy for Obstructive Sleep Apnea (OSA) of 3 escalating dose combinations of atomoxetine with AD313 compared to baseline and to atomoxetine alone.

Clinical Trial Description

The SEED study is an open-label, 4 consecutive period dose-escalation study of combinations of AD313 vs. atomoxetine alone in participants with moderate- to severe OSA. A screening polysomnogram (PSG) will be conducted to establish that each participant meets study enrollment criteria and to serve as baseline. Each participant will then receive escalating doses of AD313 with on-drug PSGs to be conducted on the final night of dosing. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05101122
Study type Interventional
Source Apnimed
Contact
Status Completed
Phase Phase 1/Phase 2
Start date October 19, 2021
Completion date April 18, 2022
View Details
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