Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04645524
• Other study ID #: APX-001
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: August 2022
• Source: Apnimed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• AD182
Oral capsule administered before bed
• AD504
Oral capsule administered before bed
• Placebo
Oral capsule administered before bed

Diagnostic Test:
• Polysomnography
for all arms

Locations

Country	Name	City	State
United States	Intrepid research, LLC	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Apnimed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)	Apnea-Hypopnea Index, AD182 and AD504 vs placebo	1 night (treatment duration)