AD109 Dose Finding in Mild to Moderate OSA

Phase 2

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: AD109 dose1- A; Drug: AD109 dose2- B; Drug: Placebo- C

• Registration Number: NCT04631107
• Lead Sponsor: Apnimed

Brief 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.

Study Timeline

• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-10
• Study First Posted: 2020-11-17
• Study Start: 2020-12-22
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Results First Submitted: 2022-08-05
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-30
• Last Update Submitted: 2022-11-30
• Results First Posted: 2022-12-22
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• AHI between 5 and 20 events/h

• PGI-S equal to or higher than 1, or one or more of the following symptoms:

  • Snoring or nightime gasping/choking
  • Daytime sleepiness, fatigue or decreased concentration
  • Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning headache
  • Irritability, decreased mood or libido

Exclusion Criteria

• History of narcolepsy.
• Clinically significant craniofacial malformation.
• Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
• CPAP should not be used for at least 2 weeks prior to the study
• History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence CBA	Placebo- C	Placebo (C), then AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A)
Sequence ABC	AD109 dose2- B	AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B), then Placebo (C).
Sequence ACB	Placebo- C	AD109 Dose 1- 75 mg (A), then Placebo (C) then AD109 Dose 2- 37.5 mg (B)
Sequence ABC	Placebo- C	AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B), then Placebo (C).
Sequence ACB	AD109 dose1- A	AD109 Dose 1- 75 mg (A), then Placebo (C) then AD109 Dose 2- 37.5 mg (B)
Sequence BCA	AD109 dose2- B	AD109 Dose 2- 37.5 mg (B), then Placebo (C), then AD109 Dose 1- 75 mg (A)
Sequence CAB	AD109 dose1- A	Placebo (C), then AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B)
Sequence ABC	AD109 dose1- A	AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B), then Placebo (C).
Sequence ACB	AD109 dose2- B	AD109 Dose 1- 75 mg (A), then Placebo (C) then AD109 Dose 2- 37.5 mg (B)
Sequence BAC	AD109 dose2- B	AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A), then Placebo (C)
Sequence BAC	Placebo- C	AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A), then Placebo (C)
Sequence BCA	AD109 dose1- A	AD109 Dose 2- 37.5 mg (B), then Placebo (C), then AD109 Dose 1- 75 mg (A)
Sequence CAB	AD109 dose2- B	Placebo (C), then AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B)
Sequence CBA	AD109 dose1- A	Placebo (C), then AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A)
Sequence CBA	AD109 dose2- B	Placebo (C), then AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A)
Sequence BAC	AD109 dose1- A	AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A), then Placebo (C)
Sequence BCA	Placebo- C	AD109 Dose 2- 37.5 mg (B), then Placebo (C), then AD109 Dose 1- 75 mg (A)
Sequence CAB	Placebo- C	Placebo (C), then AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B)

Primary Outcome Measures

Name	Time	Method
Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h]	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.
Change in Hypoxic Burden (HB) Raw Values - HB[(%*Min)/h]	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.

Trial Locations

Locations (3)

NeuroTrial Research; 🇺🇸 Atlanta, Georgia, United States

Brian Abaluck, LLC; 🇺🇸 Philadelphia, Pennsylvania, United States

Pacific Research Network; 🇺🇸 San Diego, California, United States