NCT04580394

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

October 27, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 31, 2023

Completed
Last Updated

January 31, 2023

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

October 2, 2020

Results QC Date

November 16, 2022

Last Update Submit

January 12, 2023

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]

    Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Due to the known logarithmic distribution of HB, data are primarily expressed and analyzed as Log10HB 4%\[% min/hour\]. Events with 4% or greater desaturations were included in the calculation of HB.

    1 night (treatment duration) (0-8 hours collected continuously)

Study Arms (4)

AD109

EXPERIMENTAL

Oral capsule administered before sleep

Drug: AD109Diagnostic Test: Digit System Substitution Test

Atomoxetine

ACTIVE COMPARATOR

Oral capsule administered before sleep

Drug: AtomoxetineDiagnostic Test: Digit System Substitution Test

R-oxybutynin

ACTIVE COMPARATOR

Oral capsule administered before sleep

Drug: R-oxybutyninDiagnostic Test: Digit System Substitution Test

Placebo

PLACEBO COMPARATOR

Oral capsule administered before sleep

Drug: PlaceboDiagnostic Test: Digit System Substitution Test

Interventions

AD109DRUG

Oral administration before bed

AD109
AtomoxetineDRUG

Oral administration before bed

Atomoxetine
R-oxybutyninDRUG

Oral administration before bed

R-oxybutynin
PlaceboDRUG

Oral administration before bed

Placebo
Digit System Substitution TestDIAGNOSTIC_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.

Also known as: DSST
AD109AtomoxetinePlaceboR-oxybutynin

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
  • AHI 10 to \<20, or AHI ≥20 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

Teradan Clinical Trials

Brandon, Florida, 33511, United States

Location

Clinical Trials of Florida

Miami, Florida, 33186, United States

Location

The Neurological Center of North Georgia

Gainesville, Georgia, 30501, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Results Point of Contact

Title
Clinical Trials
Organization
Apnimed, Inc.
clinicaltrials@apnimed.com
6175008880

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

October 2, 2020

First Posted

October 8, 2020

Study Start

October 27, 2020

Primary Completion

May 28, 2021

Study Completion

May 28, 2021

Last Updated

January 31, 2023

Results First Posted

January 31, 2023

Record last verified: 2022-12

Locations

US(7)