Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea

• Sponsor: Apnimed (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04645524
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 3
• Actual Duration (Months): 9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

This is a randomized, 3-period, placebo-controlled, crossover study to examine the efficacy and safety of AD182 and AD504 versus placebo in patients with obstructive sleep apnea.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Drug: AD182; Drug: AD504; Drug: Placebo	Phase 2

Detailed Description

The study is designed to examine the efficacy and safety of AD182 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 3 treatments: AD182, AD504, or Placebo. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 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, Single-Dose, 3-Period Crossover Study to Evaluate the Efficacy of AD182, and AD504 in Obstructive Sleep Apnea
• Actual Study Start Date: Dec 1, 2020
• Actual Primary Completion Date: Sep 1, 2021
• Actual Study Completion Date: Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AD182 Oral capsule administered before bed	Drug: AD182; Oral capsule administered before bed
Experimental: AD504 Oral capsule administered before bed	Drug: AD504; Oral capsule administered before bed
Placebo Comparator: Placebo Oral capsule administered before bed	Drug: Placebo; Oral capsule administered before bed

Outcome Measures

Primary Outcome Measures

1. Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep) [1 night (treatment duration)]

   Apnea-Hypopnea Index, AD182 and AD504 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:

• Male or female between 25 and 65 years of age, inclusive, at the time of the screening visit

• AHI 10 to 55 events/h if meets other PSG criteria

Exclusion Criteria:

• History of narcolepsy.

• Clinically significant craniofacial malformation.

• Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication

• CPAP should not be used for at least 2 weeks prior to first study PSG

• 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	Intrepid research, LLC	Cincinnati	Ohio	United States	45245

Sponsors and Collaborators

• Apnimed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Apnimed
• ClinicalTrials.gov Identifier: NCT04645524
• Other Study ID Numbers: APX-001
• First Posted: Nov 27, 2020
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

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

Study Results

No Results Posted as of Aug 18, 2022