AD109 Dose Finding in Mild to Moderate OSA

• Sponsor: Apnimed (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04631107
• Collaborator: (none)
• Enrollment: 32
• Locations: 3
• Arms: 3
• Actual Duration (Months): 5.3
• Patients Per Site: 10.7
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Drug: AD109 dose1; Drug: AD109 dose2; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Dec 22, 2020
• Actual Primary Completion Date: May 31, 2021
• Actual Study Completion Date: May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AD109 dose1	Drug: AD109 dose1; Oral administration at bedtime
Experimental: AD109 dose2	Drug: AD109 dose2; Oral administration at bedtime
Placebo Comparator: Placebo	Drug: Placebo; Oral administration at bedtime

Outcome Measures

Primary Outcome Measures

1. Change in Hypoxic Burden (HB) [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)

Secondary Outcome Measures

1. Apnea-Hypopnea Index [1 night (8 hours)]

   AD109 dose1 and AD109 dose2 vs placebo

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pacific Research Network	San Diego	California	United States	92103
2	NeuroTrial Research	Atlanta	Georgia	United States	30328
3	Brian Abaluck, LLC	Philadelphia	Pennsylvania	United States	19063

Sponsors and Collaborators

• Apnimed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Apnimed
• ClinicalTrials.gov Identifier: NCT04631107
• Other Study ID Numbers: APC-004
• First Posted: Nov 17, 2020
• Last Update Posted: Jun 25, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Study Results

No Results Posted as of Jun 25, 2021