NCT03845023

Brief Summary

This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels of AD036 versus 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
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

12 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

February 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

March 7, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2019

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

January 17, 2023

Completed
Last Updated

January 17, 2023

Status Verified

November 1, 2022

Enrollment Period

8 months

First QC Date

February 15, 2019

Results QC Date

November 15, 2022

Last Update Submit

December 20, 2022

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Apnea Hypopnea Index (AHI)

    Number of participants with ≥50% reduction in apnea hypopnea index (AHI). AHI is the average number of apneas and hypopneas a person experiences each hour during sleep, to register as an event an apnea or hypopnea must last at least 10 seconds or longer. To measure this, doctors divide the total number of apneic and hypopneic events by the total number of hours the person was asleep.

    10 days

Study Arms (4)

2-Night at Home

PLACEBO COMPARATOR

An initial 2-night, at-home blinded baseline period in which all subjects received placebo

Drug: Placebo

3-Night Run In

EXPERIMENTAL

AD036 Dose 1 (Low Dose: 25/5) or Placebo

Drug: AD036 Dose 1Drug: Placebo

7-Night

EXPERIMENTAL

A 7-night treatment period in which subjects received the treatment to which they were randomized, i.e., 1 of the 3 different fixed-dose combinations of drugs, or placebo

Drug: AD036 Dose 1Drug: AD036 Dose 2Drug: AD036 Dose 3Drug: Placebo

End of Study

NO INTERVENTION

End of Study Visit

Interventions

AD036 Dose 1DRUG

AD036 Dose 1 oral capsule administered before sleep

Also known as: 25/5
3-Night Run In7-Night
AD036 Dose 2DRUG

AD036 Dose 2 oral capsule administered before sleep

Also known as: 75/1.5
7-Night
AD036 Dose 3DRUG

AD036 Dose 3 oral capsule administered before sleep

Also known as: 75/5
7-Night
PlaceboDRUG

Placebo oral capsule administered before sleep

2-Night at Home3-Night Run In7-Night

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AHI ≥ 20 based on screening polysomnography
  • Epworth Sleepiness Scale (ESS) score ≥ 4 for participants not using CPAP
  • Previous surgical treatment for OSA is allowed if ≥ 1 year prior to enrollment

You may not qualify if:

  • 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.
  • Clinically significant neurological disorder, including epilepsy/convulsions.
  • Positive screen for drugs of abuse or substance use disorder as defined in DSM-V within 24 months prior to Screening Visit.
  • A significant illness or infection requiring medical treatment in the past 30 days.
  • Women who are pregnant or nursing.
  • 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.
  • History of using devices to affect participant sleeping position for the treatment of OSA, e.g. to discourage supine sleeping position, may enroll as long as the devices are not used during participation in the study.
  • Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, strong cytochrome P450 2D6 (CYP2D6) inhibitors, or monoamine oxidase inhibitors (MAOI) within 14 days of the start of treatment, or concomitant with treatment.
  • Use of another investigational agent within 90 days or 5 half-lives, whichever is longer, prior to dosing.
  • ESS total score \> 18.
  • Central apnea index \> 5/hour on baseline PSG.
  • Periodic limb movement arousal index \>15/hour on baseline PSG.
  • Hepatic transaminases \>3X the upper limit of normal (ULN), total bilirubin \>2X ULN (unless confirmed Gilbert syndrome), serum creatinine \>2X ULN.
  • \<6 hours typical sleep duration.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Pulmonary Associates

Glendale, Arizona, 85306, United States

Location

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

Stanford Sleep Medicine

Redwood City, California, 94063, United States

Location

SDS Clinical Trials, Inc.

Santa Ana, California, 92705, United States

Location

Santa Monica Clinical Trials

Santa Monica, California, 90404, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Norton Clinical Research Group

Louisville, Kentucky, 40218, 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

Clinilabs Drug Development Corporation

New York, New York, 10019, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Sleep Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

(Lys-Gly)(5)cyclo(75-82)MBP(74-85)

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Clinical Trials
Organization
Apnimed, Inc
clinicaltrials@apnimed.com
6015008880

Study Officials

  • Ron Farkas, MD

    Apnimed

    STUDY DIRECTOR

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 19, 2019

Study Start

March 7, 2019

Primary Completion

October 23, 2019

Study Completion

October 23, 2019

Last Updated

January 17, 2023

Results First Posted

January 17, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(12)