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Crossover Trial of AD109 in Obstructive Sleep Apnea

NCT04580394 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-01-31

Study results available
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Summary

This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual components or placebo in patients with obstructive sleep apnea.

Conditions

Interventions

DRUG

AD109

Oral administration before bed

DRUG

Atomoxetine

Oral administration before bed

DRUG

R-oxybutynin

Oral administration before bed

DRUG

Placebo

Oral administration before bed

DIAGNOSTIC_TEST

Digit System Substitution Test

a neuropsychological test sensitive to brain damage, dementia, age and depression where numbers are assigned symbols. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.

Sponsors & Collaborators

  • Apnimed

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-27
Primary Completion
2021-05-28
Completion
2021-05-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04580394 on ClinicalTrials.gov