NCT04445688

Brief Summary

This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to examine the efficacy and safety of AD036 versus placebo or atomoxetine 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
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

5 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

June 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 21, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

June 19, 2020

Results QC Date

July 19, 2023

Last Update Submit

September 8, 2023

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Apnea-Hypopnea Index

    Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo

    1 day

Secondary Outcomes (2)

  • Hypoxic Burden

    1 day

  • ODI

    1 day

Study Arms (3)

AD036

EXPERIMENTAL

AD036 oral capsule administered before sleep

Drug: AD036

Atomoxetine

ACTIVE COMPARATOR

Atomoxetine oral capsule administered before sleep

Drug: Atomoxetine

Placebo

PLACEBO COMPARATOR

Placebo oral capsule administered before sleep

Drug: Placebo

Interventions

AD036DRUG

Oral administration before bed

AD036
AtomoxetineDRUG

Oral administration before bed

Atomoxetine
PlaceboDRUG

Oral administration before bed

Placebo

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 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 (5)

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

SDS Clinical Trials, Inc.

Santa Ana, California, 92705, United States

Location

The Center for Sleep and Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

Sleep Medicine & Research Center, St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Related Publications (1)

  • Schweitzer PK, Maynard JP, Wylie PE, Emsellem HA, Sands SA. Efficacy of atomoxetine plus oxybutynin in the treatment of obstructive sleep apnea with moderate pharyngeal collapsibility. Sleep Breath. 2023 May;27(2):495-503. doi: 10.1007/s11325-022-02634-x. Epub 2022 May 13.

    PMID: 35551600RESULT

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
617-500-8880

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

June 19, 2020

First Posted

June 24, 2020

Study Start

July 15, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

September 14, 2023

Results First Posted

August 21, 2023

Record last verified: 2023-09

Locations

US(5)