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Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04645524
Enrollment
15
Registered
2020-11-27
Start date
2020-12-01
Completion date
2021-09-01
Last updated
2022-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

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.

Interventions

DRUGAD182

Oral capsule administered before bed

DRUGAD504

Oral capsule administered before bed

DRUGPlacebo

Oral capsule administered before bed

DIAGNOSTIC_TESTPolysomnography

for all arms

Sponsors

Apnimed
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026