CClinicalTrials.gg
Sign In
CompletedNCT03845023Updated Jan 17, 2023Results posted

Trial of AD036 in Obstructive Sleep Apnea

A Phase 2 interventional study of AD036 Dose 1 and AD036 Dose 2 in Obstructive Sleep Apnea, sponsored by Apnimed. Completed at 12 sites in United States. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-01-17.

Sponsored by Apnimed · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

This was a randomized, double-blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient, multicenter, dose-finding study of the combination of atomoxetine and oxybutynin in adults with OSA documented by polysomnography (PSG).

Approximately 140 subjects were to be randomized 1:1:1:1 to receive 1 of 3 different fixed-dose combinations of oxybutynin and atomoxetine or matching placebo.

For all subjects, the study consisted of:

  • A screening and baseline period in which subjects' eligibility was determined
  • An initial 2-night, at-home blinded baseline period in which all subjects received placebo

  • A 3-night, run-in period in which subjects received:

    • Low-dose combination for subjects randomized to one of the 3 study treatment arms
    • Placebo for subjects randomized to the placebo treatment arm
  • 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
  • An end of study visit
02

Conditions studied

  • Obstructive Sleep Apnea
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 140 is above the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Apnimed is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 6 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Male participants between 25 to 65 years of age or female participants between 25 to 70 years of age.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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.
  • Night- or shift-work sleep schedule.
  • Employment as a commercial driver or operator of heavy or hazardous equipment.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
140 participants (actual)

Study arms

  • Placebo comparator
    2-Night at Home

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

    Drug: Placebo

  • Experimental
    3-Night Run In

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

    Drug: AD036 Dose 1 · Drug: Placebo

  • Experimental
    7-Night

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

  • No intervention
    End of Study

    End of Study Visit

Interventions

  • DrugAD036 Dose 1

    AD036 Dose 1 oral capsule administered before sleep

    Also known as: 25/5

  • DrugAD036 Dose 2

    AD036 Dose 2 oral capsule administered before sleep

    Also known as: 75/1.5

  • DrugAD036 Dose 3

    AD036 Dose 3 oral capsule administered before sleep

    Also known as: 75/5

  • DrugPlacebo

    Placebo oral capsule administered before sleep

06

What researchers measure

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.

    Time frame: 10 days

07

Results

Posted Jan 17, 2023

Participant flow

Subjects were recruited from 12 clinical sites (hospitals and sleep centers). The study population consisted of male and female subjects between 25 and 65 years of age, inclusive, with OSA documented by PSG. Overall study duration was up to 8 weeks. Dosing of the study treatment was to occur approximately 30 minutes prior to bedtime. Subjects who withdrew from the study were not replaced.

Placebo Run-In Period (2 Nights)
Participant flow — Placebo Run-In Period (2 Nights)
MilestonePlaceboAD036 Dose 1AD036 Dose 2AD036 Dose 3
Started36363434
Completed36363434
Not completed0000
Low Dose Run-In (3 Nights)
Participant flow — Low Dose Run-In (3 Nights)
MilestonePlaceboAD036 Dose 1AD036 Dose 2AD036 Dose 3
Started36363434
Completed36363434
Not completed0000
Treatment Period (7 Nights)
Participant flow — Treatment Period (7 Nights)
MilestonePlaceboAD036 Dose 1AD036 Dose 2AD036 Dose 3
Started36363434
Completed36363434
Not completed0000
Follow-Up (14 Days)
Participant flow — Follow-Up (14 Days)
MilestonePlaceboAD036 Dose 1AD036 Dose 2AD036 Dose 3
Started36363434
Completed35363333
Not completed1011
Withdrew: Lost to follow-up1000
Withdrew: Adverse event0011

Outcome measures

PrimaryApnea 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.

Time frame:
10 days
Reported as:
Count of participants · Participants
Apnea Hypopnea Index (AHI)
ParticipantsPlaceboAD036 Dose 1AD036 Dose 2AD036 Dose 3
Yes (subjects that had a 50% reduction in AHI)3268
No (subjects that did not have a 50% reduction in AHI)33342826

Adverse events

Collected over Adverse events were collected over an 8 month period. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/140 (0%)0/140 (0%)7/140 (5%)
AD036 Dose 10/104 (0%)1/104 (1%)13/104 (12.5%)
AD036 Dose 20/34 (0%)0/34 (0%)16/34 (47.1%)
AD036 Dose 30/34 (0%)0/34 (0%)14/34 (41.2%)
Most frequent serious events
Most frequent serious events
EventPlaceboAD036 Dose 1AD036 Dose 2AD036 Dose 3
Acute Kidney injuryRenal and urinary disorders0/1401/1040/340/34
Most frequent other events
Showing 10 of 22
Most frequent other events
EventPlaceboAD036 Dose 1AD036 Dose 2AD036 Dose 3
Dry MouthGastrointestinal disorders2/1406/1042/348/34
headacheNervous system disorders3/1404/1047/340/34
ConstipationGastrointestinal disorders0/1402/1041/345/34
InsomniaPsychiatric disorders1/1400/1045/343/34
Urinary HesitationRenal and urinary disorders0/1402/1042/343/34
Decreased appetiteMetabolism and nutrition disorders0/1400/1042/343/34
Erectile dysfunctionReproductive system and breast disorders0/1400/1043/340/34
dyspepsiaGastrointestinal disorders2/1401/1042/340/34
Abdominal DiscomfortGastrointestinal disorders0/1400/1042/340/34
SomnolenceNervous system disorders1/1401/1042/341/34

Baseline characteristics

Data presented is from the safety population

Age, Categorical
Age, Categorical(Participants)PlaceboAD036 Dose 1AD036 Dose 2AD036 Dose 3Total
<=18 years00000
Between 18 and 65 years33353331132
>=65 years31138
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboAD036 Dose 1AD036 Dose 2AD036 Dose 3Total
Female111271242
Male2524272298
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboAD036 Dose 1AD036 Dose 2AD036 Dose 3Total
Hispanic or Latino223411
Not Hispanic or Latino34343130129
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboAD036 Dose 1AD036 Dose 2AD036 Dose 3Total
American Indian or Alaska Native00000
Asian21317
Native Hawaiian or Other Pacific Islander00011
Black or African American151081144
White1825232187
More than one race00000
Unknown or Not Reported10001
BMI (kg/m^2)
BMI (kg/m^2)(kg/m^2)PlaceboAD036 Dose 1AD036 Dose 2AD036 Dose 3Total
Median32.930 (22.74 to 40.30)33.445 (22.30 to 39.36)32.555 (20.64 to 40.17)33.170 (22.19 to 39.82)32.745 (20.64 to 40.30)
08

Study locations

12 sites
  • Pulmonary Associates
    Glendale, Arizona 85306, United States
  • Preferred Research Partners, Inc.
    Little Rock, Arkansas 72211, United States
  • Stanford Sleep Medicine
    Redwood City, California 94063, United States
  • SDS Clinical Trials, Inc.
    Santa Ana, California 92705, United States
  • Santa Monica Clinical Trials
    Santa Monica, California 90404, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Norton Clinical Research Group
    Louisville, Kentucky 40218, United States
  • The Center for Sleep and Wake Disorders
    Chevy Chase, Maryland 20815, United States
  • Sleep Medicine & Research Center, St. Luke's Hospital
    Chesterfield, Missouri 63017, United States
  • Clinilabs Drug Development Corporation
    New York, New York 10019, United States
  • CTI Clinical Research Center
    Cincinnati, Ohio 45212, United States
  • Sleep Therapy & Research Center
    San Antonio, Texas 78229, United States
09

References and documents

Study documents

  • Study protocol · Apr 12, 2019
  • Statistical analysis plan · Oct 3, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03845023
Lead sponsor
Apnimed
Responsible party
Sponsor
First posted
Feb 19, 2019
Start date
Mar 7, 2019
Primary completion
Oct 23, 2019
Completion
Oct 23, 2019
Results posted
Jan 17, 2023
Last update
Jan 17, 2023

Study contacts

Ron Farkas, MD
study director · Apnimed

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Apnea→

Other studies from this sponsor

Apnimed

Start the discussion