Obstructive Sleep ApneaPhase 2NCT04631107

AD109 Dose Finding in Mild to Moderate OSA

A Phase 2 study testing AD109 dose1- A and AD109 dose2- B in people with Obstructive Sleep Apnea, run by Apnimed at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea. Read more about this study

Who is it for?: Ages 25 to 65 years
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: AD109 dose1- A and AD109 dose2- B
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 3 sitesUnited States
Study dates: 22 Dec 2020to 31 May 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

AHI between 5 and 20 events/h
PGI-S equal to or higher than 1, or one or more of the following symptoms:
Snoring or nightime gasping/choking
Daytime sleepiness, fatigue or decreased concentration
Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning headache
Irritability, decreased mood or libido

Who cannot join

History of narcolepsy.
Clinically significant craniofacial malformation.
Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
CPAP should not be used for at least 2 weeks prior to the study
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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

NeuroTrial Research
Atlanta, Georgia, 30328
Brian Abaluck, LLC
Philadelphia, Pennsylvania, 19063
Pacific Research Network
San Diego, California, 92103

Other trials in United States

About this study

Official title: Phase 2 Randomized Double-Blind Placebo-Controlled 3-Period Single-Dose Crossover Study to Evaluate the Safety and Efficacy of Two Doses of AD-109 in Mild to Moderate Obstructive Sleep Apnea

This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.

Read the detailed description

Participants underwent initial pre-screening to determine potential study eligibility. Participants selected for further screening had either a previous history of OSA of a severity consistent with enrollment criteria or were at high risk (e.g. as assessed by STOP-Bang Questionnaire score). Only participants who met all non polysomnography (PSG) enrollment criteria at Visit 1 were eligible for a screening PSG.

Conditions: Obstructive Sleep Apnea
Being tested: AD109 dose1- A, AD109 dose2- B, Placebo- C
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AD109 dose1- ADrug
Also called AD109 75
Oral administration at bedtime
AD109 dose2- BDrug
Also called AD109 37.5
Oral administration at bedtime
Placebo- CDrug
Oral administration at bedtime

Study groups in NCT04631107
Study group	Role	What they receive
Sequence ABC	Other	AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B), then Placebo (C). Receives: Drug: AD109 dose1- A; Drug: AD109 dose2- B; Drug: Placebo- C
Sequence ACB	Other	AD109 Dose 1- 75 mg (A), then Placebo (C) then AD109 Dose 2- 37.5 mg (B) Receives: Drug: AD109 dose1- A; Drug: AD109 dose2- B; Drug: Placebo- C
Sequence BAC	Other	AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A), then Placebo (C) Receives: Drug: AD109 dose1- A; Drug: AD109 dose2- B; Drug: Placebo- C
Sequence BCA	Other	AD109 Dose 2- 37.5 mg (B), then Placebo (C), then AD109 Dose 1- 75 mg (A) Receives: Drug: AD109 dose1- A; Drug: AD109 dose2- B; Drug: Placebo- C
Sequence CAB	Other	Placebo (C), then AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B) Receives: Drug: AD109 dose1- A; Drug: AD109 dose2- B; Drug: Placebo- C
Sequence CBA	Other	Placebo (C), then AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A) Receives: Drug: AD109 dose1- A; Drug: AD109 dose2- B; Drug: Placebo- C

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h]
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/h]. Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.
Measured: 1 night (8 hours)
Change in Hypoxic Burden (HB) Raw Values - HB[(%*Min)/h]
Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas.
Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.
Measured: 1 night (8 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Dec 202031 May 2021

First posted17 Nov 2020
Study start22 Dec 2020
Primary completion31 May 2021
Study completion31 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04631107
Sponsor's protocol ID: APC-004
Status last verified: Nov 2022
First submitted: 6 Nov 2020
Last updated: 22 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Rosenberg R, Abaluck B, Thein S. Combination of atomoxetine with the novel antimuscarinic aroxybutynin improves mild to moderate OSA. J Clin Sleep Med. 2022 Dec 1;18(12):2837-2844. doi: 10.5664/jcsm.10250.
PubMed 35975547

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
RecruitingObservational study
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Obstructive Sleep Apnea Syndrome
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
Apnea, Sleep Disorders
Active, not recruitingPhase 3
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Randomized Double-Blind Placebo-Controlled 3-Period Single-Dose Crossover Study to Evaluate the Safety and Efficacy of Two Doses of AD-109 in Mild to Moderate Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT04631107
Acronym / sponsor ID: APC-004
Conditions: Obstructive Sleep Apnea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: ApnimedIndustry (pharma, biotech, devices)
Study start: 22 Dec 2020 (actual)
Primary completion: 31 May 2021 (actual)
Study completion: 31 May 2021 (actual)
First posted: 17 Nov 2020 (actual)
Results: Posted 22 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Sequence ABC	Other	Drug: AD109 dose1- A, Drug: AD109 dose2- B, Drug: Placebo- CAD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B), then Placebo (C).
Sequence ACB	Other	Drug: AD109 dose1- A, Drug: AD109 dose2- B, Drug: Placebo- CAD109 Dose 1- 75 mg (A), then Placebo (C) then AD109 Dose 2- 37.5 mg (B)
Sequence BAC	Other	Drug: AD109 dose1- A, Drug: AD109 dose2- B, Drug: Placebo- CAD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A), then Placebo (C)
Sequence BCA	Other	Drug: AD109 dose1- A, Drug: AD109 dose2- B, Drug: Placebo- CAD109 Dose 2- 37.5 mg (B), then Placebo (C), then AD109 Dose 1- 75 mg (A)
Sequence CAB	Other	Drug: AD109 dose1- A, Drug: AD109 dose2- B, Drug: Placebo- CPlacebo (C), then AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B)
Sequence CBA	Other	Drug: AD109 dose1- A, Drug: AD109 dose2- B, Drug: Placebo- CPlacebo (C), then AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A)

Who may qualify

Ages: 25 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

AHI between 5 and 20 events/h
PGI-S equal to or higher than 1, or one or more of the following symptoms:

Key exclusion criteria (5 listed)

History of narcolepsy.
Clinically significant craniofacial malformation.
Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
CPAP should not be used for at least 2 weeks prior to the study
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AD109 dose1- AAlso: AD109 75Oral administration at bedtime	Drug	Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA
AD109 dose2- BAlso: AD109 37.5Oral administration at bedtime	Drug	Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA
Placebo- COral administration at bedtime	Drug	Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA

Primary outcome

Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h]
Time frame: 1 night (8 hours)
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/h]. Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.
Change in Hypoxic Burden (HB) Raw Values - HB[(%*Min)/h]
Time frame: 1 night (8 hours)
Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.

Results and safety

Results posted to the registry on 22 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	32	31

Primary outcome: Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h]

Time frame: 1 night (8 hours). Mean (95% Confidence Interval). Unit: difference in log10HB[(%*min)/h]

Measure	AD109 dose1 vs Placebo n = 27	AD109 dose2 vs Placebo n = 27	Dose 2 vs Dose 1 n = 27
Value	-0.40 (-0.54 to -0.25)	-0.21 (-0.36 to -0.07)	0.18 (0.04 to 0.33)

Primary outcome: Change in Hypoxic Burden (HB) Raw Values - HB[(%*Min)/h]

Time frame: 1 night (8 hours). Mean (95% Confidence Interval). Unit: (%*min)/h

Measure	AD109 dose1 vs Placebo n = 27	AD109 dose2 vs Placebo n = 27	Dose 2 vs Dose 1 n = 27
Value	-6.90 (-10.20 to -3.60)	-4.70 (-8.01 to -1.38)	2.20 (-1.23 to 5.36)

Adverse events

Time frame: Adverse Events were collected for each subject for up to 12 weeks. The overall study duration was up to 12 weeks (Screening period, up to 4 weeks; 3-period crossover, up to 6 weeks; End of Study Evaluation, 2 weeks post crossover period).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AD109 dose1	0 of 30 (0%)	4 of 30 (13.3%)	0 of 30
AD109 dose2	0 of 28 (0%)	2 of 28 (7.1%)	0 of 28
Placebo	0 of 29 (0%)	2 of 29 (6.9%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35975547Rosenberg R, Abaluck B, Thein S. Combination of atomoxetine with the novel antimuscarinic aroxybutynin improves mild to moderate OSA. J Clin Sleep Med. 2022 Dec 1;18(12):2837-2844. doi: 10.5664/jcsm.10250.

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
RecruitingObservational study
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Obstructive Sleep Apnea Syndrome
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
Apnea, Sleep Disorders
Active, not recruitingPhase 3
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ron Farkas, MD study director

Apnimed

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AD109 dose1- A and AD109 dose2- B in people with Obstructive Sleep Apnea, run by Apnimed at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h] (time frame: 1 night (8 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04631107, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.