Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea

NCT04645524 | Completed Phase 2 FDA Drug

• 1 other identifier: APX-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

AD182

EXPERIMENTAL

Oral capsule administered before bed

Drug: AD182; Diagnostic Test: Polysomnography

AD504

EXPERIMENTAL

Oral capsule administered before bed

Drug: AD504; Diagnostic Test: Polysomnography

Placebo

PLACEBO COMPARATOR

Oral capsule administered before bed

Drug: Placebo; Diagnostic Test: Polysomnography

Interventions

AD182 DRUG

Oral capsule administered before bed

AD182

AD504 DRUG

Oral capsule administered before bed

AD504

Placebo DRUG

Oral capsule administered before bed

Placebo

Polysomnography DIAGNOSTIC_TEST

for all arms

AD182; AD504; Placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Apnimed: lead

Study Sites (1)

Intrepid research, LLC

Cincinnati, Ohio, 45245, United States

Location

Related Publications (1)

• Corser B, Eves E, Warren-McCormick J, Rucosky G. Effects of atomoxetine plus a hypnotic on obstructive sleep apnea severity in patients with a moderately collapsible pharyngeal airway. J Clin Sleep Med. 2023 Jun 1;19(6):1035-1042. doi: 10.5664/jcsm.10464.

  PMID: 36734173 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Bruce Corser, MD

  Intrepid Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2020
• First Posted: November 27, 2020
• Study Start: December 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 2, 2022

Record last verified: 2022-08

Locations

US (1)