NCT04631107

AD109 Dose Finding in Mild to Moderate OSA

Phase 2 Randomized Double-Blind Placebo-Controlled 3-Period Single-Dose Crossover Study to Evaluate the Safety and Efficacy of Two Doses of AD-109 in Mild to Moderate Obstructive Sleep Apnea

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Apnimed · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.

Detailed description

Participants underwent initial pre-screening to determine potential study eligibility. Participants selected for further screening had either a previous history of OSA of a severity consistent with enrollment criteria or were at high risk (e.g. as assessed by STOP-Bang Questionnaire score). Only participants who met all non polysomnography (PSG) enrollment criteria at Visit 1 were eligible for a screening PSG.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	AD109 dose1- A	Oral administration at bedtime
DRUG	AD109 dose2- B	Oral administration at bedtime
DRUG	Placebo- C	Oral administration at bedtime

Timeline

• Start date: 2020-12-22
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2020-11-17
• Last updated: 2022-12-22
• Results posted: 2022-12-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study